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Study identifier: NCT07185191 Synced from ClinicalTrials.gov · July 29, 2026
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Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)

Condition: Black Triangles Syndrome (BTS) · Periodontal Gingival Contraction  ·  Sponsor: Mastelli S.r.l

PhaseNA
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 as soft tissue flaps or augmentation. Some invasive surgical methods proposed for papilla reconstruction and correction of black triangle recession include repeated interproximal curettage, Beagle's pedicle graft procedure, free epithelialized and de-epithelialized gingival grafts, and subepithelial connective tissue grafts. The success rate of surgical augmentation depends on the thickness of the gingiva biotype. Orthodontic treatment can also be used to reshape and decrease the embrasure space. An alternative option is minimally invasive procedures for tissue re-volumizing and papilla anatomical-functional reconstruction. Hyaluronic acid (HA) has been used for minimally invasive papilla reconstruction, leveraging its volumizing filler effect. Non-surgical strategies based on hyaluronan are gaining ground internationally. The immediate goal of minimally invasive treatment for interdental papilla loss and black triangle disease is mechanical protection and gingival restoration. Promoting tissue hydration, fibroblast vitality, and collagen deposition may offer a long-term regenerative medicine solution. Additionally, natural-origin, High Purification Technology Polynucleotides (PN HPTTM) are exploited for wound healing and counteracting connective tissue depletion. PNs-based med…

This description comes directly from the study's public registry record.

Talk to the study team

Molinari  ·  + 39 039 39951  ·  silvia.molinari@cr-technology.com

Always discuss trial participation with your own doctor first.

Locations (1)

Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di BresciaBrescia, Italy, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07185191