Gingival Black TriangleRBBCMNCT04482790
Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method
A study testing Conventional celluloid matrix technique in management of black triangle and Bioclear cervical matrix with injection molding technique in people with Gingival Black Triangle, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of bioclear matrix and injection molding technique against conventional celluloid matrix technique in management of black triangle. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Black Triangle
- What is being tested?
- Conventional celluloid matrix technique in management of black triangle and Bioclear cervical matrix with injection molding technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 11553
Aya Omar Tawfik, MD, 01002877503 ext. 002, ayaomar8846@gmail.com
Shereen H Ibrahim, A.professor, 01099296591 ext. 002, shereen.hafez@dentistry.cu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Black Triangle
- Being tested
- Conventional celluloid matrix technique in management of black triangle, Bioclear cervical matrix with injection molding technique
- Keywords
- black triangle, bio-clear cervical matrix, dental esthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional celluloid matrix technique in management of black triangleProcedure or surgery
conventional restorative technique in management of black triangle
Bioclear cervical matrix with injection molding techniqueProcedure or surgery
New restorative technique in management of black triangle restorative papilla regeneration
| Study group | Role | What they receive |
|---|---|---|
| Conventional celluloid matrix | Active comparator | Conventional celluloid matrix technique in management of black triangle Receives: Procedure: Conventional celluloid matrix technique in management of black triangle |
| Bioclear cervical matrix | Experimental | Bioclear cervical matrix with injection molding technique in management of black triangle Receives: Procedure: Bioclear cervical matrix with injection molding technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic evaluation
Scoring system according to World Dental Federation (FDI) criteria
Measured: 12 months
Secondary outcomes (1)
Marginal adaptation
Scoring system according to FDI criteria from one to five one represents very good clinically restoration \& five represents poor clinically restoration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Black TriangleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Omar Tawfik Hussien, Cairo University
- Investigators
- Aya O Hussien, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482790
- Sponsor's protocol ID
- CEBD-CU-2019-8-23
- Acronym
- RBBCM
- Status last verified
- Jul 2020
- First submitted
- 22 Mar 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37330484
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Black Triangle With Bioclear Matrix and Injection Molding Technique Versus Celluloid Conventional Matrix Method: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04482790
- Acronym / sponsor ID
- RBBCM / CEBD-CU-2019-8-23
- Conditions
- Gingival Black Triangle
- Keywords
- black triangle, bio-clear cervical matrix, dental esthetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional celluloid matrix | Active comparator | Procedure: Conventional celluloid matrix technique in management of black triangleConventional celluloid matrix technique in management of black triangle |
| Bioclear cervical matrix | Experimental | Procedure: Bioclear cervical matrix with injection molding techniqueBioclear cervical matrix with injection molding technique in management of black triangle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients eligible for the trial must comply with all of the following:
Key exclusion criteria (8 listed)
- Cl III according to Nordland and Tarnow classification
- Uncontrolled parafunction.
- Insufficient oral hygiene
- Periodontal and gingival diseases
- Pregnant and nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional celluloid matrix technique in management of black triangleconventional restorative technique in management of black triangle | Procedure or surgery | Conventional celluloid matrix |
| Bioclear cervical matrix with injection molding techniqueNew restorative technique in management of black triangle restorative papilla regeneration | Procedure or surgery | Bioclear cervical matrix |
Primary outcome
Esthetic evaluation
Time frame: 12 months
Scoring system according to World Dental Federation (FDI) criteria
1 secondary outcome
Marginal adaptation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Derived from this study: PubMed 37330484Hussien 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.
Related trials for Gingival Black Triangle
Recruiting
Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)
Black Triangles Syndrome (BTS), Periodontal Gingival Contraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya O Hussien, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional celluloid matrix technique in management of black triangle and Bioclear cervical matrix with injection molding technique in people with Gingival Black Triangle, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Omar Hussien, MD (01002877503 ext. 002, ayaomar8846@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.