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Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01420536
Enrollment
44
Registered
2011-08-19
Start date
2009-02-28
Completion date
2011-06-30
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaw, Edentulous Mouth

Keywords

Bilateral Balanced Occlusion, Canine Guidance, Complete Denture, Denture Retention, Dental Occlusion, Edentulous, Edentulism, Mandibular movement, Mastication, Patient Acceptance of Health Care, Patient Satisfaction

Brief summary

The objective of this study is to compare the canine guidance (CG) and bilateral balanced occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.

Detailed description

Reference for published version of the complete study: Paleari AG, Marra J, Rodriguez LS, De Souza RF, Pero AC, De A Mollo Jr F, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures.J Oral Rehabil. 2012 Apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. \[Epub ahead of print\]

Interventions

PROCEDUREOcclusal scheme

Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept. Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients needing new complete dentures * Mentally receptiveness * Absence of dysfunctional disorders of the masticatory system * Normal volume and resilience of residual edentulous ridges * Absence of debilitating systemic diseases

Exclusion criteria

* Use of cardiac pacemaker * Refusal to participate or inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Denture Satisfaction30 daysAssessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).

Secondary

MeasureTime frameDescription
Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis30 daysMandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Countries

Brazil

Participant flow

Recruitment details

Recruitment period: July to December 2012. Convenience sample composed by 50 patients, who had volunteered to receive new complete dentures at Araraquara Dental School - UNESP.

Pre-assignment details

Participants waited 30 days following the completion of treatment, in order to have them functionally adapted to their new dentures. Six spontaneously declined to participate before random assignment due to lack of interest.

Participants by arm

ArmCount
Canine Guidance, Then Bilateral Balanced Occlusion
Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
22
Bilateral Balanced Occlusion Then Canine Guidance
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92);
22
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001
Period 1 (30 Days)Withdrawal by Subject30

Baseline characteristics

CharacteristicBilateral Balanced Occlusion Then Canine GuidanceCanine Guidance, Then Bilateral Balanced OcclusionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants11 Participants22 Participants
Age, Categorical
Between 18 and 65 years
11 Participants11 Participants22 Participants
Age, Continuous66.4 years
STANDARD_DEVIATION 10.3
65.5 years
STANDARD_DEVIATION 10.6
66.0 years
STANDARD_DEVIATION 10.5
Region of Enrollment
Brazil
22 participants22 participants44 participants
Sex: Female, Male
Female
14 Participants14 Participants28 Participants
Sex: Female, Male
Male
8 Participants8 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 440 / 41
serious
Total, serious adverse events
0 / 440 / 41

Outcome results

Primary

Denture Satisfaction

Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).

Time frame: 30 days

Population: Convenience sampling.

ArmMeasureValue (MEDIAN)
Canine GuidanceDenture Satisfaction15 units on a scale
Bilateral Balanced OcclusionDenture Satisfaction15 units on a scale
Comparison: Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.p-value: 0.569Wilcoxon (Mann-Whitney)
Secondary

Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis30.3 mmStandard Deviation 4.5
Bilateral Balanced OcclusionKinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis30.9 mmStandard Deviation 4.6
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.339t-test, 2 sided
Secondary

Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis25.1 mmStandard Deviation 9.4
Bilateral Balanced OcclusionKinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis25.8 mmStandard Deviation 8.8
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.515t-test, 2 sided
Secondary

Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis1.4 mmStandard Deviation 1.3
Bilateral Balanced OcclusionKinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis1.7 mmStandard Deviation 2.4
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.485t-test, 2 sided
Secondary

Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (2.a) Rest Position, Vertical Axis2.1 mmStandard Deviation 1.2
Bilateral Balanced OcclusionKinesiographic Parameters -- (2.a) Rest Position, Vertical Axis2.3 mmStandard Deviation 1.1
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.111t-test, 2 sided
Secondary

Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis1.9 mmStandard Deviation 1
Bilateral Balanced OcclusionKinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis1.9 mmStandard Deviation 0.9
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.399t-test, 2 sided
Secondary

Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (2.c) Rest Position, Left-right Axis0.5 mmStandard Deviation 0.5
Bilateral Balanced OcclusionKinesiographic Parameters -- (2.c) Rest Position, Left-right Axis0.4 mmStandard Deviation 0.3
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.55t-test, 2 sided
Secondary

Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis12.0 mmStandard Deviation 2.7
Bilateral Balanced OcclusionKinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis12.1 mmStandard Deviation 2.7
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.609t-test, 2 sided
Secondary

Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis4.2 mmStandard Deviation 2.1
Bilateral Balanced OcclusionKinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis4.3 mmStandard Deviation 2
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.6t-test, 2 sided
Secondary

Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis1.2 mmStandard Deviation 2.1
Bilateral Balanced OcclusionKinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis1.3 mmStandard Deviation 1.4
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.611t-test, 2 sided
Secondary

Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis-0.5 mmStandard Deviation 0.4
Bilateral Balanced OcclusionKinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis-0.6 mmStandard Deviation 0.3
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.044t-test, 2 sided
Secondary

Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis-0.4 mmStandard Deviation 0.7
Bilateral Balanced OcclusionKinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis-0.4 mmStandard Deviation 0.4
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.677t-test, 2 sided
Secondary

Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis

Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Canine GuidanceKinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis-0.1 mmStandard Deviation 0.5
Bilateral Balanced OcclusionKinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis-0.1 mmStandard Deviation 0.3
Comparison: For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.p-value: 0.885t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026