A Clinical Trial of Proximal Composite Restorations (Automatrix)

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

Study Overview

• Status: Completed
• Conditions: Class II Caries in Premolars
• Intervention / Treatment: Device: Separation ring; Device: automatrix band

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 Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Dental Clinics, Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Separation ring; Separation ring placed along with automatrix band; Other Names: BiTine® Separation ring by Palodent, product # 659040); Device: automatrix band; band placed with a tightening device; Other Names: circumferential automatrix band by Dentsply
Active Comparator: 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.	Device: automatrix band; band placed with a tightening device; Other Names: circumferential automatrix band by Dentsply

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overhang of the restoration	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 the restoration placement)

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Farhan R Khan, FCPS, AKU

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: proximal caries, composite restoration, proximal contact
• Other Study ID Numbers: 640-Sur-ERC-06; 640-Sur/ERC-06 (Other Identifier: Aga khan University)