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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Class II Caries in Posterior Teeth
• Intervention / Treatment: Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad Capital Territory
    • Islamabad, Islamabad Capital Territory, Pakistan
      • Recruiting
      • School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proximal contacts tightness	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).	immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal contours and overhangs	To be examined clinically with an explorer and mouth mirror and then on the radiograph by the blinded co investigator.	immediately after procedure

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (ACTUAL): June 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SOD/ERB/2022/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No