A Clinical Trial of Proximal Composite Restorations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-12-31

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

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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.

Conditions

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Class II Caries in Premolars

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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automatrix band, 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.

Group Type EXPERIMENTAL

Separation ring

Intervention Type DEVICE

Separation ring placed along with automatrix band

automatrix band

Intervention Type DEVICE

band placed with a tightening device

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.

Group Type ACTIVE_COMPARATOR

automatrix band

Intervention Type DEVICE

band placed with a tightening device

Interventions

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Separation ring

Separation ring placed along with automatrix band

Intervention Type DEVICE

automatrix band

band placed with a tightening device

Intervention Type DEVICE

Other Intervention Names

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BiTine® Separation ring by Palodent, product # 659040) circumferential automatrix band by Dentsply

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes