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

Not Applicable

• Conditions: Class II Caries in Posterior Teeth
• Interventions: Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix

• Registration Number: NCT05414656
• Lead Sponsor: Pakistan Institute of Medical Sciences

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.

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 Timeline

• Study Start: 2022-05-02
• Status Verified: 2022-06
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Study First Posted: 2022-06-10
• Last Update Posted: 2022-06-10
• Primary Completion: 2022-09
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B:pre-contoured self-adhesive matrix	Saddle contoured metal matrix, 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.
Group A : Saddle contoured metal matrix	Saddle contoured metal matrix, Pre-contoured self-adhesive 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad; 🇵🇰 Islamabad, Islamabad Capital Territory, Pakistan