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Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs

Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03702881
Enrollment
50
Registered
2018-10-11
Start date
2017-06-09
Completion date
2020-04-15
Last updated
2021-05-12

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

Conditions

Malocclusion, Open Bite

Keywords

Open Bite, Orthodontic appliance, Cephalometry, Dental models

Brief summary

This study compares the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients. Half of participants will be treated with bonded spurs associated with build-ups, while the other half will be treated with conventional bonded spurs. The null hypothesis to be tested is that there are no differences for the dentoalveolar and skeletal effects between the two protocols.

Detailed description

Anterior open bite is commonly related with lower anterior face height increase. Some early treatment protocols use appliances that control deleterious habits associated to appliances that produce control of the vertical dimension. Usually, these appliances (chincup, removable orthopedics) depend on patient's collaboration. Recently, the efficiency and stability of anterior open bite treatment with resin blocks bonded to the posterior teeth (build-ups) associated with fixed orthodontic appliances was described. They could be considered as a promissory alternative for vertical control during anterior open bite treatment. Then, it could be thought that the association of bonded spurs with posterior build-ups, instead of chincup, would produce vertical control during anterior open bite early treatment without the need of patient collaboration. Therefore, the aim of this study is to compare the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients. For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. Fifty patients between 7 and 11 years old diagnosed with anterior open bite greater than 1 mm will be prospective and randomly allocated in one of the two study group. The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups. Control group will consist of 25 patients treated with conventional bonded spurs. Lateral radiographs and digital dental models will be obtained at the beginning (T1), 12 months after treatment (T2), and 24 months after treatment (T3). Dentoalveolar and skeletal variables will be evaluated from the lateral radiographs in the Dolphin® software. Dental casts will be analyzed with the Orthoanalyzer® software to evaluate dentoalveolar anterior vertical development, posterior teeth inclinations and arch dimensions. Superimposition of digital dental models will be performed to evaluate the relative three-dimensional dentoalveolar changes on the maxillary and mandibular arches. Discomfort, pain and quality of life will be evaluated using questionnaires. After verifying the normal distribution, intergroup comparisons (T1 vs T2 and T1 vs T3) will be performed with t test and intragroup comparisons with dependent t test. Results will be considered statistically significant at P\<0.05. The possible harms that could appear with these therapies are related to temporary tongue discomfort during the first days after the installation of the appliances. Patients and parents will be informed that is it normal. Although it has been reported that the discomfort is temporary and transitory and usually patients adapted to the treatment after 3-5 days, patients or parents will be able to stop the treatment at any moment.

Interventions

DEVICEBonded Spurs associated with posterior build-ups

Twenty-five patients will be treated with bonded spurs associated with posterior build-ups. The cervical portion of the palatal surfaces of the maxillary incisors and the incisal portion of the lingual surfaces of the mandibular incisors will be pumiced, rinsed, dried, and acid etched with 37% phosphoric acid. The etched surfaces will be subsequently rinsed and carefully dried. Then, the spurs will be bonded using Transbond primer/adhesive. The positions for the spurs will be chose to prevent possible future occlusal interferences The spurs will be sharpened with a carborundum disk before bonding. In addition, posterior build-ups (resin blocks) will be cemented on the functional cusps of all maxillary posterior teeth. The treatment time will be 12 months. After this time, the posterior build ups will be removed and the bonded spurs will be maintained for 12 months more, as active retention.

DEVICEConventional bonded spurs

Twenty-five patients will be treated only with bonded spurs. The bonding of the spurs will follow the same protocol described for the experimental group. The treatment time will be 12 months. After this time, the bonded spurs will be maintained for 12 months more, as active retention.

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* Patients between 7 to 11 years old, * erupted permanent first permanent molars, * anterior open bite (AOB) greater than 1 mm, * maxillary and mandibular permanent central incisors fully erupted, * no or mild crowding, * without the need of maxillary expansion * Children in the first transitional period will be considered to be eligible for treatment when the maxillary lateral incisors are beginning to erupt and the maxillary central incisors still show an open bite

Exclusion criteria

* previous orthodontic treatment, * craniofacial anomalies or syndromes, * tooth agenesis, * loss of permanent teeth, * severe crowding, * maxillary constriction or posterior crossbite

Design outcomes

Primary

MeasureTime frame
Overbite (mm)12 months
Gonial angle (º)12 months
Mandibular plane angle (º)12 months
Maxillary and mandibular molar vertical development (mm)12 months

Secondary

MeasureTime frameDescription
Overbite (mm)24 months
Gonial angle (º)24 months
Mandibular plane angle (º)24 months
Maxillary and mandibular molar vertical development (mm)24 months
Maxillary and mandibular position (º)12 months
Maxillary and mandibular length (mm)12 months
Mandibular ramus height (mm)12 months
Sagittal skeletal discrepancy (º)12 months
Facial axis angle (º)12 months
Maxillomandibular divergence angle (º)12 months
Overjet (mm)12 months
Maxillary and mandibular incisors Inclination (º)12 months
Maxillary and mandibular incisors position (mm)12 months
Maxillary and mandibular incisors height (mm)12 months
Anterior face height (mm)12 months
Upper lip inclination (º)12 months
Upper and lower lip position (mm)12 months
Interlabial gap (mm)12 months
Maxillary and mandibular anterior dentoalveolar vertical development (mm)12 months
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)12 months
Maxillary and mandibular inter-first permanent molar distances (mm)12 months
Maxillary and mandibular inter-canine distances (mm)12 months
Maxillary and mandibular arch perimeters (mm)12 months
Maxillary and mandibular arch lengths (mm)12 months
Palatal depth (mm)12 months
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)12 months
Discomfort and pain intensity evaluated with questionnaires1 monthA 10-cm Visual Analog Scale will be used, where 0-cm is the minimum score indicating nor discomfort or pain intensity and 10-cm is the maximum score denoting the greatest discomfort or pain intensity.
Parent´s perception of children discomfort and pain intensity evaluated with questionnaires1 monthA 10-cm Visual Analog Scale will be used, where 0-cm is the minimum score indicating nor discomfort or pain intensity and 10-cm is the maximum score denoting the greatest discomfort or pain intensity.
Quality of life evaluation with questionnaires12 monthsOral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from 0 indicating no impact of oral condition on quality of life, to 100 indicating maximal impact of oral condition on quality of life.
Nasolabial angle (º)12 months
Posterior face height (mm)12 months
Lower anterior face height (mm)12 months
Palatal plane inclination (º)12 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026