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Clinical and Radiographic Evaluation of Two Matrix Systems for Restoration of Class II Cavities in Primary Molars

Assessment of Clinical, Radiographical Efficacy, Operator Ease and Satisfaction and Patient Comfort in Restoring Class II Cavities in Primary Molars With Fender Mate System Versus T-Band System: An in Vivo Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06447324
Enrollment
20
Registered
2024-06-07
Start date
2024-07-01
Completion date
2024-10-30
Last updated
2024-06-10

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

Conditions

Tooth Decay, Tooth Restoration

Keywords

Matrix Systems, Class II Cavities, Primary Molars

Brief summary

this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.

Detailed description

Restorations of posterior primary teeth can have a number of issues, including incorrect contact points and proximal overhangs. With the recognition of significance of restoring tooth's right contour and contact, and repair of all tooth surfaces, including proximal walls, different matrix systems were introduced,so this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.

Interventions

DEVICEFender Mate matrix system

Matrix Systems used for Restoration of Class II Cavities in Primary Molars

DEVICET-band matrix

Matrix Systems used for Restoration of Class II Cavities in Primary Molars

Sponsors

Aswan University
Lead SponsorOTHER

Study design

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

Intervention model description

two groups

Eligibility

Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

1. Apparently healthy children free from any systemic diseases. 2. Patients showing Frankel's positive and definitely positive behavior. 3. Parent willing to participate in the study and signed on informed consent. 4. Each child has at least two carious primary molars (class II) bilaterally, indicated for composite restoration with criteria as follow: - * No history of spontaneous pain or provoked pain. * Fully erupted teeth. * Fully erupted adjacent tooth. * Caries involving two surfaces - proximal and occlusal * Absence of clinical signs or symptoms suggesting a non-vital tooth such as sinus tract, soft tissue swelling, mobility or tenderness to percussion. * No pathological external or internal root resorption.

Exclusion criteria

1. Patients showing Frankel's negative and definitely negative behavior. 2. Children having primary molars with: * Caries involving less than or more than two surfaces * Extensively damaged teeth * Missing adjacent tooth. * Mobility. * Spaced dentition.

Design outcomes

Primary

MeasureTime frameDescription
Clinical assessment of Proximal Contact PointsBaselineclinically assessment of the Proximal Contact Points using waxed dental floss in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Radiographically Assessment of proximal overhangsBaselineRadiographically Assessment of the proximal overhangs using bite wing radiograph in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Assessment of operator ease and satisfactionBaseline-Assessment of operator ease and satisfaction using questionnaire in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix, which includes: 1. time needed to install the matrix system (more time means worse outcome) 2. Ease of application and removal of matrix system which may be Easy, Manageable or Difficult (Difficult means worse outcome) 3. Trauma to gingival tissue while applying and removing matrix system which may be Present or Absent (Present means worse outcome) 4. Dislodgment/displacement of restoration while removing matrix system which may be Yes or NO (Yes means worse outcome)
Assessment of patient comfortBaseline* Assessment of patient comfort using Wong Baker pain rating scale in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix. * Wong Baker pain rating scale with scores from 0-10 (higher scores mean a worse outcome).

Contacts

Primary ContactNoha El-Sayed Fathi Abdou, Lecturer
noha_elsayed1@dent.suez.edu.eg01288737074
Backup ContactAsmaa Ali Emam Abo-Elsoud, Assoc. Prof
asmaa_ali@dent.suez.edu.eg01220989854

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026