Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method (RBBCM)

July 22, 2020 updated by: Aya Omar Tawfik Hussien, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional celluloid matrix
Conventional celluloid matrix technique in management of black triangle
Procedure: Conventional celluloid matrix technique in management of black triangle
conventional restorative technique in management of black triangle
Experimental: Bioclear cervical matrix
Bioclear cervical matrix with injection molding technique in management of black triangle
Procedure: Bioclear cervical matrix with injection molding technique
New restorative technique in management of black triangle restorative papilla regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esthetic evaluation
Time Frame: 12 months
Scoring system according to World Dental Federation (FDI) criteria
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal adaptation
Time Frame: 12 months
Scoring system according to FDI criteria from one to five one represents very good clinically restoration & five represents poor clinically restoration
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phonetics
Time Frame: 12 months
Visual Analogue Scale (VAS) from zero to ten ,zero represents none & ten represent sever
12 months
Food impaction
Time Frame: 12 months
Visual Analogue Scale
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Aya O Hussien, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

March 22, 2020

First Submitted That Met QC Criteria

July 18, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-CU-2019-8-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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