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

NCT ID: NCT05414656

Last Updated: 2022-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Class II Caries in Posterior Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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nosheen sarwar

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

Islamabad, Islamabad, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Nosheen Sarwar, BDS

Role: CONTACT

+923088895652

References

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Sarwar N, Khokhar SA. Comparison of saddle contoured metal matrix and pre-contoured self-adhesive matrix in composite resin class II restorations; an in vivo study. J Pak Med Assoc. 2024 Feb;74(2):209-215. doi: 10.47391/JPMA.8627.

Reference Type DERIVED
PMID: 38419215 (View on PubMed)

Other Identifiers

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SOD/ERB/2022/02

Identifier Type: -

Identifier Source: org_study_id

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