Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method

Gingival Black Triangle Clinical Trial

— RBBCM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482790
• Other study ID #: CEBD-CU-2019-8-23
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: Aya Omar Hussien, MD
• Phone: 01002877503
• Email: ayaomar8846[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Black Triangle

Intervention

Procedure:
• Conventional celluloid matrix technique in management of black triangle
conventional restorative technique in management of black triangle
• Bioclear cervical matrix with injection molding technique
New restorative technique in management of black triangle restorative papilla regeneration

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phonetics	Visual Analogue Scale (VAS) from zero to ten ,zero represents none & ten represent sever	12 months
Other	Food impaction	Visual Analogue Scale	12 months
Primary	Esthetic evaluation	Scoring system according to World Dental Federation (FDI) criteria	12 months
Secondary	Marginal adaptation	Scoring system according to FDI criteria from one to five one represents very good clinically restoration & five represents poor clinically restoration	12 months