Status:
NOT_YET_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)
Lead Sponsor:
Mastelli S.r.l
Collaborating Sponsors:
Clinical Research Technology S.r.l.
Conditions:
Black Triangles Syndrome (BTS)
Periodontal Gingival Contraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The treatment of black triangles in modern dentistry involves various approaches, both surgical and nonsurgical. Surgical methods aim to reconstruct or preserve gingival tissue using techniques such a...
Eligibility Criteria
Inclusion
- Be able to provide written informed consent (ICF) for the study.
- Males and females.
- Be aged 18 years or older at the time of signing the informed consent.
- Subjects have to show at least one anterior interdental papilla recession in the smile zone according to Jemt's classification (BTS).
- The teeth near the interdental papilla recession must have the contact point.
- Absence of periodontal diseases.
- Subjects with adequate knowledge of domiciliary oral hygiene practices, as measured by the following parameters: FMPS (full mouth plaque score) and FMBS (full mouth bleeding score) values \<10%.
- Absence of plaque and bleeding on probing at the site of interest.
- Absence of retentive factors at the site of interest.
Exclusion
- Subjects with active periodontitis.
- Presence of an acute infection in the oral cavity or upper respiratory tract.
- Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the end of the treatment.
- Subjects must not be Smokers more than 10 cigarettes per day.
- Presence of bleeding disorders or taking medications that affect blood clotting (e.g., coumarin-type drugs or platelet aggregation inhibitors).
- Presence of systemic diseases that could affect periodontal health.
- Patients with autoimmune diseases.
- Known or suspected allergy to seafood products.
- Psychiatric or behavioral disorders or substance abuse that would interfere with the necessary cooperation for the study.
- Presence of infra-bony defects associated with pocket or papilla contraction and visible on X-ray as well as detectable on probing.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07185191
Start Date
February 1 2026
End Date
November 1 2027
Last Update
December 2 2025
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