Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method

NCT ID: NCT04482790

Last Updated: 2020-07-24

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Gingival Black Triangle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional celluloid matrix

Conventional celluloid matrix technique in management of black triangle

Group Type ACTIVE_COMPARATOR

Conventional celluloid matrix technique in management of black triangle

Intervention Type PROCEDURE

conventional restorative technique in management of black triangle

Bioclear cervical matrix

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

Group Type EXPERIMENTAL

Bioclear cervical matrix with injection molding technique

Intervention Type PROCEDURE

New restorative technique in management of black triangle restorative papilla regeneration

Interventions

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Conventional celluloid matrix technique in management of black triangle

conventional restorative technique in management of black triangle

Intervention Type PROCEDURE

Bioclear cervical matrix with injection molding technique

New restorative technique in management of black triangle restorative papilla regeneration

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Omar Tawfik Hussien

Assistant lecturer in conservative department of faculty of dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aya O Hussien, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya Omar Hussien, MD

Role: CONTACT

01002877503 ext. 002

shereen H Ibrahim, A.professor

Role: CONTACT

01099296591 ext. 002

Facility Contacts

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Aya Omar Tawfik, MD

Role: primary

01002877503 ext. 002

Shereen H Ibrahim, A.professor

Role: backup

01099296591 ext. 002

References

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Hussien AOT, Ibrahim SH, Essa MES, Hafez RM. Restoring black triangle with bioclear matrix versus conventional celluloid matrix method: a randomized clinical trial. BMC Oral Health. 2023 Jun 17;23(1):402. doi: 10.1186/s12903-023-03102-y.

Reference Type DERIVED
PMID: 37330484 (View on PubMed)

Other Identifiers

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CEBD-CU-2019-8-23

Identifier Type: -

Identifier Source: org_study_id

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