Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07185191

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

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 medical devices are widely used in Europe and other countries for various indications, including orthopedics (intra-articular administration), dermatology (intra-dermal injections), and vulvo-vaginal application.

PNs have minimal protein contaminants and allergic risks due to advanced purification techniques. Their hydrophilic nature provides hydration and acts as a volume enhancer. Recent in vitro studies demonstrate improved gingival fibroblast viability and collagen deposition with PNs.

The purpose of this clinical investigation is to assess the safety and clinical performance of RDM36 in the treatment of periodontal gingival contraction and in black triangles syndrome (BTS).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Black Triangles Syndrome (BTS) Periodontal Gingival Contraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia

Brescia, Italy, 25123

Location status: Recruiting

Location contact

Struttura Complessa (S.C.) di Odontostomatologia

CONTACT

[email protected]

+ 39 039 39951

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

RDM36

Device

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

Saline Solution (NaCl 0,9%)

Drug

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

Primary outcomes

  1. Occurrence of adverse device effects (ADE) and serious adverse device effects (SADE) - Safety outcome

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

  2. Clinical performance of RDM36 in the 2D modification of the "black triangle" lesion through photographic documentation using Image-J software obtained from a scan (TRIOS 6 3Shape intraoral scanner) and from superimposition compared to baseline

    Time frame: Visit 2 (6 ± 1 weeks)

Secondary outcomes

  1. Clinical performance of RDM36 in the 2D modification of the "black triangle" lesion through photographic documentation using Image-J software obtained from a scan (TRIOS 6 3Shape intraoral scanner) and from superimposition compared to baseline

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

  2. Patients' subjective evaluation of the aesthetic improvement of black triangle syndrome through the Visual Analogue Scale (VAS, 0-10 score, where 0=very satisfactory and 10=unsatisfactory)

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

  3. Patients' subjective evaluation of the aesthetic improvement of black triangle syndrome through the Global Aesthetic Improvement Scale (GAIS)

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

    GAIS, rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse)

  4. Patients' subjective evaluation of the aesthetic improvement of black triangle syndrome through the Likert scale

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

    5 point-Likert scale, from 1 to 5 indicating how satisfied is the patient (1 - Extremely dissatisfied, 5 - Extremely satisfied)

  5. Evaluation of the clinical performance of RDM36 in the 3D modification of the "black triangle" lesion through a scanner volumetric analysis (TRIOS 6 3Shape) and Blender software.

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

  6. Papilla's colorimetric evaluation using a colorimeter (OPTISHADE STYLEITALIANO) that will objectively rank the stability or improvement of gingival health on a red scale

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

  7. Periodontal health evaluation through Plaque Index (PI)

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

    The PI is a dichotomous parameters (0 = absence, 1 = presence)

  8. Periodontal health evaluation through Bleeding on Probing (BOP)

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

    The BOP is a dichotomous parameters (0 = absence, 1 = presence)

  9. Periodontal health evaluation through Recession (REC) at the study site

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

    REC is measured in millimeters (PD: < 4 mm = health, > 4mm = periodontal disease)

  10. Periodontal health evaluation through Probing Depth (PD) at the study site

    Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline

    PD is measured in millimeters (PD: < 4 mm = health, > 4mm = periodontal disease)

Study contacts

Contact information is provided by the study sponsor or research team.

Molinari

CONTACT

[email protected]

+ 39 039 39951

Sponsors and collaborators

Lead sponsor

Mastelli S.r.l

Industry

Collaborators

  • Clinical Research Technology S.r.l.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.