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

Not Applicable

Not yet recruiting

• Conditions: Tooth Decay; Tooth Restoration
• Interventions: Device: Fender Mate matrix system; Device: T-band matrix

• Registration Number: NCT06447324
• Lead Sponsor: Aswan University

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-02
• Study First Submitted QC: 2024-06-02
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-10
• Study Start: 2024-07-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fender Mate matrix group	Fender Mate matrix system	Twenty primary molars will be restored with composite restoration using the Fender Mate matrix
Conventional T-band matrix group	T-band matrix	Twenty primary molars will be restored with composite restoration using T-band matrix

Primary Outcome Measures

Name	Time	Method
Clinical assessment of Proximal Contact Points	Baseline	clinically 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 overhangs	Baseline	Radiographically 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 satisfaction	Baseline	-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 comfort	Baseline	* 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).