Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04482790

Acronym

RBBCM

Enrollment

Registered

2020-07-23

Start date

2020-03-01

Completion date

2021-05-01

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Black Triangle

Keywords

black triangle, bio-clear cervical matrix, dental esthetics

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.

Interventions

PROCEDUREConventional celluloid matrix technique in management of black triangle

conventional restorative technique in management of black triangle

PROCEDUREBioclear cervical matrix with injection molding technique

New restorative technique in management of black triangle restorative papilla regeneration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Egypt

Contacts

Primary ContactAya Omar Hussien, MD

ayaomar8846@gmail.com01002877503

Backup Contactshereen H Ibrahim, A.professor

shereen.hafez@dentistry.cu.edu.eg01099296591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026