A Clinical Trial of Proximal Composite Restorations (Automatrix)
This study has been completed.
Sponsor:
Aga Khan University
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
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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 |
Resource links provided by NLM:
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 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 May 16, 2013