Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

November 1, 2027

Study Completion Date

November 1, 2027

Conditions
Black Triangles Syndrome (BTS)Periodontal Gingival Contraction
Interventions
DEVICE

RDM36

Patients treated with RDM36; two perpendicular infiltrations (buccal, palatal) of a quantity of 0.2 ml of PN HPT

DRUG

Saline Solution (NaCl 0,9%)

patients treated with saline solution; two perpendicular infiltrations (buccal, palatal) of a quantity of 0.2 ml of saline solution

Sponsors
All Listed Sponsors
collaborator

Clinical Research Technology S.r.l.

INDUSTRY

lead

Mastelli S.r.l

INDUSTRY