A Clinical Trial of Proximal Composite Restorations (Automatrix)

Aga Khan University

Status: Completed

Conditions: Class II Caries in Premolars

Treatments: Device: automatrix band; Device: Separation ring

Study type: Interventional

Funder types: Other

Identifiers

NCT01662388

640-Sur/ERC-06 (Other Identifier)

640-Sur-ERC-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

automatrix band, Separation ring

Experimental group

Description:

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.

Treatment:

Device: Separation ring

Device: automatrix band

automatrix band

Active Comparator group

Description:

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.

Treatment:

Device: automatrix band