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Clinical Trials/NCT04482790
NCT04482790UnknownNot Applicable

Restoring Black Triangle With Bioclear Matrix and Injection Molding Technique Versus Celluloid Conventional Matrix Method: A Randomized Clinical Trial

Cairo University1 site in 1 country26 target enrollmentStarted: March 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
26
Locations
1
Primary Endpoint
Esthetic evaluation

Study Overview

Brief Summary

Assessment of bioclear matrix and injection molding technique against conventional celluloid matrix technique in management of black triangle.

Detailed Description

Patients with black triangle defect in anterior teeth (Cl I and Cl II according to Nordland and Tarnow classification) managed by Bioclear matrix with injection molding technique and conventional celluloid matrix technique.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients eligible for the trial must comply with all of the following:
  • •Cl I and cl II according to Nordland and Tarnow classification
  • •Good oral hygiene
  • •Good general health
  • •Cooperative patient
  • •Subjects who signed the informed consent
  • •Patient compliance

Exclusion Criteria

  • •Cl III according to Nordland and Tarnow classification
  • •Uncontrolled parafunction.
  • •Insufficient oral hygiene
  • •Periodontal and gingival diseases
  • •Pregnant and nursing
  • •Disabilities
  • •Systemic disease or severe medical complications
  • •Lack of compliance

Arms & Interventions

Conventional celluloid matrix

Active Comparator

Conventional celluloid matrix technique in management of black triangle

Intervention: Conventional celluloid matrix technique in management of black triangle (Procedure)

Bioclear cervical matrix

Experimental

Bioclear cervical matrix with injection molding technique in management of black triangle

Intervention: Bioclear cervical matrix with injection molding technique (Procedure)

Outcomes

Primary Outcomes

Esthetic evaluation

Time Frame: 12 months

Scoring system according to World Dental Federation (FDI) criteria

Secondary Outcomes

  • Marginal adaptation(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aya Omar Tawfik Hussien

Assistant lecturer in conservative department of faculty of dentistry

Cairo University

Study Sites (1)

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