Black Triangles Syndrome (BTS)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)
A study testing RDM36 and Saline Solution (NaCl 0,9%) in people with Black Triangles Syndrome (BTS) and Periodontal Gingival Contraction, run by Mastelli S.r.l at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Black Triangles Syndrome (BTS), Periodontal Gingival Contraction
- What is being tested?
- RDM36 and Saline Solution (NaCl 0,9%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
Brescia, Italy, 25123
Struttura Complessa (S.C.) di Odontostomatologia, + 39 039 39951, studi.clinici@asst-spedalicivili.it
About this study
Official 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
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.
Read more
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).
- Being tested
- RDM36, Saline Solution (NaCl 0,9%)
- Keywords
- BTS, Polynucleotides, Black Triangles Syndrome, PN HPT, Papilla, Tissue deficits, gingival contraction, Periodontal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDM36Device
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (RDM36) | Experimental | Not described Receives: Device: RDM36 |
| Control group | Sham comparator | Not described Receives: Drug: Saline Solution (NaCl 0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse device effects (ADE) and serious adverse device effects (SADE) - Safety outcome
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
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
Measured: Visit 2 (6 ± 1 weeks)
Secondary outcomes (10)
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
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
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)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Patients' subjective evaluation of the aesthetic improvement of black triangle syndrome through the Global Aesthetic Improvement Scale (GAIS)
GAIS, rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Patients' subjective evaluation of the aesthetic improvement of black triangle syndrome through the Likert scale
5 point-Likert scale, from 1 to 5 indicating how satisfied is the patient (1 - Extremely dissatisfied, 5 - Extremely satisfied)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
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.
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Papilla's colorimetric evaluation using a colorimeter (OPTISHADE STYLEITALIANO) that will objectively rank the stability or improvement of gingival health on a red scale
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Periodontal health evaluation through Plaque Index (PI)
The PI is a dichotomous parameters (0 = absence, 1 = presence)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Periodontal health evaluation through Bleeding on Probing (BOP)
The BOP is a dichotomous parameters (0 = absence, 1 = presence)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Periodontal health evaluation through Recession (REC) at the study site
REC is measured in millimeters (PD: < 4 mm = health, > 4mm = periodontal disease)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Periodontal health evaluation through Probing Depth (PD) at the study site
PD is measured in millimeters (PD: < 4 mm = health, > 4mm = periodontal disease)
Measured: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start2 Apr 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black Triangles Syndrome (BTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mastelli S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Technology S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185191
- Sponsor's protocol ID
- SHAPE STUDY
- Status last verified
- May 2026
- First submitted
- 6 Aug 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07185191
- Acronym / sponsor ID
- SHAPE STUDY
- Keywords
- BTS, Polynucleotides, Black Triangles Syndrome, PN HPT, Papilla, Tissue deficits, gingival contraction, Periodontal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mastelli S.r.lIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Technology S.r.l.
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (RDM36) | Experimental | Device: RDM36 |
| Control group | Sham comparator | Drug: Saline Solution (NaCl 0,9%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDM36Patients treated with RDM36; two perpendicular infiltrations (buccal, palatal) of a quantity of 0.2 ml of PN HPT | Device | Treatment group (RDM36) |
| 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 | Drug | Control group |
Primary outcome
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
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)
10 secondary outcomes
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
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
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
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
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
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
Periodontal health evaluation through Plaque Index (PI)
Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
Periodontal health evaluation through Bleeding on Probing (BOP)
Time frame: From enrollment to the end of treatment at 26 weeks (± 2 weeks) from baseline
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Black Triangles Syndrome (BTS)
Not yet recruiting
Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction
Loss of Interdental Papillae, Black Triangles Syndrome (BTS)
Recruiting
Clinical Evaluation of Different Treatments for Interdental Black Triangles
Black Triangles Syndrome (BTS), Papilla Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDM36 and Saline Solution (NaCl 0,9%) in people with Black Triangles Syndrome (BTS) and Periodontal Gingival Contraction, run by Mastelli S.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molinari (+ 39 039 39951, silvia.molinari@cr-technology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.