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

Pakistan Institute of Medical Sciences

Status: Enrolling

Conditions: Class II Caries in Posterior Teeth

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05414656

SOD/ERB/2022/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group A : Saddle contoured metal matrix

Experimental group

Description:

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.

Treatment:

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

Group B:pre-contoured self-adhesive matrix

Active Comparator group

Description:

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

Treatment:

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