A Clinical Trial of Proximal Composite Restorations (Automatrix)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Farhan Raza Khan, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01662388
First received: August 8, 2012
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Class II Caries in Premolars
Device: Separation ring
Device: automatrix band

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Proximal Composite Restorations

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • proximal tightness [ Time Frame: 1 day (just after dental restoration) ] [ Designated as safety issue: No ]
    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:
  • proximal contours [ Time Frame: 1 day (just after restoration placement) ] [ Designated as safety issue: No ]
    To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.


Other Outcome Measures:
  • Overhang of the restoration [ Time Frame: 1 day (just after the restoration placement) ] [ Designated as safety issue: No ]
    To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.


Enrollment: 188
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BiTine® Separation ring by Palodent, product # 659040)
Device: automatrix band
band placed with a tightening device
Other Name: 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 Name: circumferential automatrix band by Dentsply

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662388

Locations
Pakistan
Dental Clinics, Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Farhan R Khan, FCPS AKU
  More Information

No publications provided

Responsible Party: Farhan Raza Khan, Assistant Professor, Dentistry, Aga Khan University
ClinicalTrials.gov Identifier: NCT01662388     History of Changes
Other Study ID Numbers: Proximal composite, 640-Sur/ERC-06
Study First Received: August 8, 2012
Last Updated: August 9, 2012
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
proximal caries, composite restoration, proximal contact

ClinicalTrials.gov processed this record on April 17, 2014