A Clinical Trial of Proximal Composite Restorations

Study Overview
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Brief Summary
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Several techniques have been advocated to get good contacts in dental composite restorations including interdental separation ring. The investigators study focuses on using separation ring with circumferential matrix band instead of a sectional band. 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 188 premolar teeth with proximal cavity to be assigned on alternate basis in two groups. Intervention group teeth received Automatrix band after cavity preparation followed by the separation ring using clamp while the control group received Automatrix band alone. All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA). Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.

Official Title
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A Clinical Trial of Proximal Composite Restorations

Conditions
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Class II Caries in Premolars

Intervention / Treatment
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* Device: Separation ring
* Device: automatrix band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who had supra gingival Class II cavities in permanent premolars. Teeth with cavity isthmus less than one-third of intercuspal distance were inducted Exclusion Criteria: Partially erupted teeth, teeth with non-carious tooth surface wear or with orthodontic bands or brackets or whose adjacent tooth continuous with the cavity side is missing were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: automatrix band, Separation ring<br>The prepared teeth received Automatrix band (similar to the control group, product code# 62422513). The Automatrix was burnished against the adjacent tooth gently. Anatomical wedges were applied in the proximal area and then the separation ring (BiTine® round ring by Palodent systems, Dentsply International, DE, USA product # 659040) placed with the help of retainer forceps. | Device: Separation ring<br>* Separation ring placed along with automatrix band<br>* Other names: BiTine® Separation ring by Palodent, product # 659040);Device: automatrix band<br>* band placed with a tightening device<br>* Other names: circumferential automatrix band by Dentsply;|
| Active Comparator: automatrix band<br>Teeth received Automatrix band alone (Wide-Regular type, dimensions 7.9 mm height and 0.05mm thickness, product code # 62422513). It was secured on the prepared tooth and burnished against the adjacent tooth gently. Anatomical wedges were placed in the inter-proximal area gingival to the cavity preparation. | Device: automatrix band<br>* band placed with a tightening device<br>* Other names: circumferential automatrix band by Dentsply;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proximal tightness | The tightness of the proximal contact area resulting from either of the two matrix band system. It was measured using a nine inch long nylon dental floss (Johnson and Johnson, USA). | 1 day (just after dental restoration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proximal contours | To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator. | 1 day (just after restoration placement) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal caries, composite restoration, proximal contact