A Clinical Trial of Proximal Composite Restorations

Not Applicable

Completed

• Conditions: Class II Caries in Premolars
• Interventions: Device: Separation ring; Device: automatrix band

• Registration Number: NCT01662388
• Lead Sponsor: Aga Khan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
automatrix band, Separation ring	Separation ring	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.
automatrix band, Separation ring	automatrix band	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.
automatrix band	automatrix band	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.

Primary Outcome Measures

Name	Time	Method
proximal tightness	1 day (just after dental restoration)	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).

Secondary Outcome Measures

Name	Time	Method
proximal contours	1 day (just after restoration placement)	To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.

Trial Locations

Locations (1)

Dental Clinics, Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan