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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Molinari
• Email: silvia.molinari@cr-technology.com
• Phone: + 39 039 39951

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatments to reduce interdental black triangles

  This trial will try three methods—surgical tube grafting, hyaluronic acid injections, and a composite injection-molding technique—to close or reduce interdental black triangles in adults with mild to moderate papilla loss.

  Recruiting Ain Shams University · Cairo · NCT07548203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.