A Clinical Trial of Proximal Composite Restorations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- proximal tightness
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Separation ring (Device)
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.
Intervention: automatrix band (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.
Intervention: automatrix band (Device)
Outcomes
Primary Outcomes
proximal tightness
Time Frame: 1 day (just after dental restoration)
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 Outcomes
- proximal contours(1 day (just after restoration placement))
Investigators
Farhan Raza Khan
Assistant Professor, Dentistry
Aga Khan University