RDM36 injections to rebuild gum papilla and reduce 'black triangles'

A Pre-market Randomized Clinical Trial to Evaluate the Safety and Clinical, Functional and Aesthetic Benefits of Polynucleotide (PN HPT™) Infiltration in the Treatment of Interdental Papilla and Marginal Soft Tissue Deficits

This trial will test injections of RDM36 (compared with saline) to try to restore interdental papilla volume and reduce black triangles in adults with papilla recession.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mastelli S.r.l (industry)
• Locations: 1 site (Brescia, Italy)
• Trial ID: NCT07185191 on ClinicalTrials.gov

What this trial studies

This interventional study compares RDM36, a polynucleotide-based injectable medical device intended to re-volumize gingival papilla, with saline control in adults who have anterior interdental papilla recession (black triangles). Eligible participants must be 18 or older, have at least one papilla recession in the smile zone with contact points present, and show excellent oral hygiene without active periodontal disease. The procedure is minimally invasive, delivering the device into papilla sites, with follow-up visits to record safety and performance outcomes. The trial is sponsored by Mastelli S.r.l and conducted at a single center in Brescia, Italy.

Who should consider this trial

Good fit: Adults (18+) with at least one anterior interdental papilla recession in the smile zone, intact contact points, no active periodontal disease, and excellent oral hygiene are ideal candidates.

Not a fit: People with active periodontitis, local oral infections, inadequate oral hygiene or bleeding at the site, missing contact points, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, RDM36 could increase papilla volume to reduce black triangles and improve dental aesthetics while avoiding more invasive surgical grafting.

How similar studies have performed: Hyaluronic acid fillers have been used in published case series with some success for papilla reconstruction, while polynucleotide-based devices like RDM36 are newer and have more limited published clinical evidence.

Eligibility criteria

Inclusion Criteria:

1. Be able to provide written informed consent (ICF) for the study.
2. Males and females.
3. Be aged 18 years or older at the time of signing the informed consent.
4. Subjects have to show at least one anterior interdental papilla recession in the smile zone according to Jemt's classification (BTS).
5. The teeth near the interdental papilla recession must have the contact point.
6. Absence of periodontal diseases.
7. 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%.
8. Absence of plaque and bleeding on probing at the site of interest.
9. Absence of retentive factors at the site of interest.

Exclusion Criteria:

1. Subjects with active periodontitis.
2. Presence of an acute infection in the oral cavity or upper respiratory tract.
3. Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the end of the treatment.
4. Subjects must not be Smokers more than 10 cigarettes per day.
5. Presence of bleeding disorders or taking medications that affect blood clotting (e.g., coumarin-type drugs or platelet aggregation inhibitors).
6. Presence of systemic diseases that could affect periodontal health.
7. Patients with autoimmune diseases.
8. Known or suspected allergy to seafood products.
9. Psychiatric or behavioral disorders or substance abuse that would interfere with the necessary cooperation for the study.
10. Presence of infra-bony defects associated with pocket or papilla contraction and visible on X-ray as well as detectable on probing.

Where this trial is running

Brescia, Italy

• Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia — Brescia, Italy, Italy (RECRUITING)

Study contacts

• Study coordinator: Molinari

Conditions: Black Triangles Syndrome, Periodontal Gingival Contraction, BTS, Polynucleotides, PN HPT, Papilla, Tissue deficits, gingival contraction