A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands

Sponsor

Pakistan Institute of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05414656

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.

Condition or Disease	Intervention/Treatment	Phase
Class II Caries in Posterior Teeth	Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix	N/A

Detailed Description

A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation.

All teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations

Actual Study Start Date :

May 2, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A : Saddle contoured metal matrix The prepared teeth received the Saddle contoured metal matrix. The saddle clip of matrix connect the band and secured around prepared cavity wall. The anatomical wedge placed into the gingival embrasure to maintain the height of gingival floor and ensure the optimal adaptation of the matrix band in the cervical region.	Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.
Active Comparator: Group B:pre-contoured self-adhesive matrix Teeth received the Pre-contoured self adhesive matrix with anatomical wedges. The adhesive end of band closed around the prepared cavity.	Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.

Arm

Intervention/Treatment

Experimental: Group A : Saddle contoured metal matrix

The prepared teeth received the Saddle contoured metal matrix. The saddle clip of matrix connect the band and secured around prepared cavity wall. The anatomical wedge placed into the gingival embrasure to maintain the height of gingival floor and ensure the optimal adaptation of the matrix band in the cervical region.

Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix

Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.

Active Comparator: Group B:pre-contoured self-adhesive matrix

Teeth received the Pre-contoured self adhesive matrix with anatomical wedges. The adhesive end of band closed around the prepared cavity.

Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix

Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.

Outcome Measures

Primary Outcome Measures

proximal contacts tightness [immediately after procedure]
The tightness of the proximal contact area resulting from Saddle contoured metal matrix and pre-contoured self-adhesive matrix . It was measured using a nine inch long nylon dental floss (Oral-B, USA).

Secondary Outcome Measures

Proximal contours and overhangs [immediately after procedure]
To be examined clinically with an explorer and mouth mirror and then on the radiograph by the blinded co investigator.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

• Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration.
The patient who has adjacent teeth available for the contact with surrounding tooth structure.
Teeth with cavity isthmus less than one-third of inter-cuspal distance

Exclusion Criteria:

• Partially erupted or deciduous teeth.
Teeth with orthodontic bands or brackets.
3rd Molar and rotated teeth.
Teeth with dental caries extending up to pulp with periapical pathosis or periodontally weak teeth.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad	Islamabad	Islamabad Capital Territory	Pakistan

Sponsors and Collaborators

Pakistan Institute of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

nosheen sarwar, Principle Investigator, Pakistan Institute of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05414656

Other Study ID Numbers:

SOD/ERB/2022/02

First Posted:

Jun 10, 2022

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 10, 2022