A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands

Study Overview
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Brief Summary
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Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.

Detailed Description
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A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation. All teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.

Official Title
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Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations

Conditions
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Class II Caries in Posterior Teeth

Intervention / Treatment
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* Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration. The patient who has adjacent teeth available for the contact with surrounding tooth structure. Teeth with cavity isthmus less than one-third of inter-cuspal distance Exclusion Criteria: • Partially erupted or deciduous teeth. Teeth with orthodontic bands or brackets. 3rd Molar and rotated teeth. Teeth with dental caries extending up to pulp with periapical pathosis or periodontally weak teeth.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A : Saddle contoured metal matrix<br>The prepared teeth received the Saddle contoured metal matrix. The saddle clip of matrix connect the band and secured around prepared cavity wall. The anatomical wedge placed into the gingival embrasure to maintain the height of gingival floor and ensure the optimal adaptation of the matrix band in the cervical region. | Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix<br>* Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.<br>|
| Active Comparator: Group B:pre-contoured self-adhesive matrix<br>Teeth received the Pre-contoured self adhesive matrix with anatomical wedges. The adhesive end of band closed around the prepared cavity. | Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix<br>* Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proximal contacts tightness | The tightness of the proximal contact area resulting from Saddle contoured metal matrix and pre-contoured self-adhesive matrix . It was measured using a nine inch long nylon dental floss (Oral-B, USA). | immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal contours and overhangs | To be examined clinically with an explorer and mouth mirror and then on the radiograph by the blinded co investigator. | immediately after procedure |