[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mastelli S.r.l\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100607179","evaluation-of-the-safety-and-performance-of-the-medical-device-rdm36-in-the-treatment-of-periodontal-gingival-contraction-and-in-black-triangles-syndrome-bts-100607179",false,"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 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","Inclusion Criteria:\n\n1. Be able to provide written informed consent (ICF) for the study.\n2. Males and females.\n3. Be aged 18 years or older at the time of signing the informed consent.\n4. Subjects have to show at least one anterior interdental papilla recession in the smile zone according to Jemt's classification (BTS).\n5. The teeth near the interdental papilla recession must have the contact point.\n6. Absence of periodontal diseases.\n7. 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 \\\u003C10%.\n8. Absence of plaque and bleeding on probing at the site of interest.\n9. Absence of retentive factors at the site of interest.\n\nExclusion Criteria:\n\n1. Subjects with active periodontitis.\n2. Presence of an acute infection in the oral cavity or upper respiratory tract.\n3. Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the end of the treatment.\n4. Subjects must not be Smokers more than 10 cigarettes per day.\n5. Presence of bleeding disorders or taking medications that affect blood clotting (e.g., coumarin-type drugs or platelet aggregation inhibitors).\n6. Presence of systemic diseases that could affect periodontal health.\n7. Patients with autoimmune diseases.\n8. Known or suspected allergy to seafood products.\n9. Psychiatric or behavioral disorders or substance abuse that would interfere with the necessary cooperation for the study.\n10. Presence of infra-bony defects associated with pocket or papilla contraction and visible on X-ray as well as detectable on probing.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.\n\nAn 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.\n\nNon-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.\n\nPNs-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.\n\nPNs 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.\n\nThe 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).",[26,27],"Black Triangles Syndrome (BTS)","Periodontal Gingival Contraction",[29,30,31,32,33,34,35,36],"BTS","Polynucleotides","Black Triangles Syndrome","PN HPT","Papilla","Tissue deficits","gingival contraction","Periodontal","RECRUITING","2026-05-08",{"date":40,"type":41},"2026-05-12","ACTUAL",{"date":43,"type":41},"2026-04-02",{"date":45,"type":20},"2027-12-01",{"name":47,"class":48},"Mastelli S.r.l","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":49},"100604618","clinical-investigation-on-a-polynucleotide-based-device-used-to-improve-skin-hydration-100604618","NCT07151859","Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration","A Pre-market, Two-stages, Monocentric, Interventional, Single-arm, Clinical Investigation to Evaluate the Safety and the Performance of PN30 (RDM16) for the Improvement of Skin Hydration","Inclusion Criteria:\n\n1. Subject Informed consent form (ICF) signed;\n2. Female and male Subjects aged 18-70 years;\n3. Subjects desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of neck or décolleté.\n4. Healthy skin;\n5. Willingness to discontinue all dermatological treatment and procedures during the study;\n6. Willingness to follow all study procedures, including attending all site visits, tests and examinations;\n7. Agreeing to present at each study visit without face\u002Fneck\u002Fdécolleté cosmetics;\n8. Accepting to not change their habits regarding food, physical activity, face\u002Fneck\u002Fdécolleté cosmetics and cleansing products;\n9. Willingness to follow indications to avoid make-up in the 12 hours following the injection treatment and to avoid any prolonged exposure to the sun, UV rays and temperatures below 0°C, as well as any sauna or hammam sessions at least until the wheals have been fully reabsorbed;\n10. Skin phototype I-IV according to Fitzpatrick's classification.\n\nExclusion Criteria:\n\n1. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with\u002Fwithout ongoing antitumor therapy);\n2. Infectious or inflammatory processes near the area of intervention;\n3. Presence of cutaneous disease on the tested area, as malformations and recurrent facial\u002Flabial herpes;\n4. Presence of tendon, bone or muscular implants near the area of intervention;\n5. Ongoing cutaneous allergies;\n6. Allergy or contraindications to device components;\n7. Concomitant intake of anticoagulant or antiplatelet medications;\n8. Subjects who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;\n9. Immune system illnesses\u002Fdisease;\n10. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);\n11. Treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), or drugs able to influence the test results in the investigator opinion, within 5 days prior to study inclusion;\n12. Known drug and\u002For alcohol abuse;\n13. Mental incapacity that precludes adequate understanding or cooperation;\n14. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, botulinum toxin injections, chemical peeling, fillers) of the treated area within 6 months prior to study inclusion;\n15. Pregnancy or breastfeeding;\n16. Participation in another investigational study within 1 month prior to study inclusion.",true,"70 Years",{"count":60,"type":20},43,[23],"Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging. Injectable anti-aging products have been widely used for aesthetic improvement of the skin.\n\nIn recent years, new filler products made from High Purification Technology Polynucleotides (PN HPTTM) have been developed and are now being used in Europe. PN HPTTM has a consolidated utilization in the aesthetic field and recently, specific guidelines in their utilization have been implemented. Polynucleotides (PNs) are polymeric chains formed by purines, pyrimidines, deoxyribonucleotides, and deoxyribonucleosides that can be found in cells throughout the human body. PNs have viscoelastic properties and the capability to bind, reorganize and orientate a high concentration of water molecules, creating 3D gel that undergoes an enzymatic cleavage.\n\nOn this basis, polynucleotide-containing products act as short-time temporary fillers to produce a volumizing effect and exert a lubricant and moisturizing action, due to the high concentration of water molecules. Moreover, they maintain for a long time the moisturizing and viscoelastic effect.\n\nA recent report which summarizes the findings and recommendations issued from the Italian Scientific Board of aesthetic physicians, supports the use of PN-HPT.\n\nIn this context, the Sponsor has developed PN30, a soft-tissue filler containing PN-HPT (at a concentration of 30 mg\u002F mL) as functional ingredients which help improve skin turgor and elasticity due to their moisturizing and viscoelastic properties.\n\nPN30 is a new device with no history of marketing but based on a similar product CE marked developed and sold by the Manufacturer with less amount of PN (2%). Therefore, the aim of this pre-market, twostages, monocentric, interventional, single-arm, clinical investigation is to evaluate the safety and the performance of PN30 (RDM16) for the improvement of skin hydration. The clinical investigation is planned as an adaptative two-stages study.\n\nThe planned procedures will be the same for both stages. The primary objective\u002Fendpoint of STAGE I will be to evaluate the safety, while the primary objective\u002Fendpoint of STAGE II will be to evaluate the performance of the device.",[64,65,66,67,68],"Aesthetic Improvement of the Skin","Skin Hydration in Healthy Volunteers","Skin Elasticity","Skin Turgor","Subject Satisfaction",[70,30,32,71,72,73,74,75,76,77,78],"aesthetic","skin","skin quality","skin elasticity","skin turgor","skin hydration","face","neck","décolleté","2026-01-30",{"date":81,"type":41},"2026-02-03",{"date":83,"type":41},"2025-09-18",{"date":85,"type":20},"2027-03-31",{"name":47,"class":48},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":49},"100578303","clinical-benefits-and-safety-of-tropho-tend-in-the-management-of-painful-rotator-cuff-tendinopathy-100578303","NCT06809543","Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy","Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy (RCT)","Inclusion Criteria\n\n* Male and female patients ≥ 18 years of age, in good general health condition.\n* Painful Rotator Cuff Tendinopathy (RCT) since ≥ 6 weeks.\n* Pain and impaired functionality on a 0 to 10 cm-centimeter specifically designed Visual Analogue Scale (VAS) ≥ 4 cm at baseline visit.\n* Rotator Cuff Tendinopathy (RCT) diagnosis, based on clinical examination.\n* Tendon ultrasound (EUS) performed within one month of enrollment.\n* Signed written informed consent.\n\nExclusion Criteria\n\n* Treatment with any investigational product within 6 months prior to clinical investigation entry.\n* Patients with known hypersensitivity to the products (active compound and excipients) or any component or procedure used in the clinical investigation.\n* Patients with para-tendinopathy, partial\u002Ftotal rupture, previous tendon surgery.\n* Severe intercurrent illness (e.g.: uncontrolled diabetes mellitus, peripheral neuropathy, autoimmune or inflammatory condition, metabolic disorders, severe oncological conditions) that, in the opinion of the investigator, may put the patient at risk when participating in the clinical investigation or affect the patient's ability to take part in the clinical investigation .\n* Patients treated with systemic and\u002For local steroids within the last 6 months, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.\n* Recent history of drug and\u002For alcohol abuse (within the last 6 months).\n* Pregnant or breastfeeding women",{"count":95,"type":20},60,[23],"This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT).\n\nAll subjects will be involved in the clinical investigation for 4 months for a total of 5 visits (T0= basal visit, T1, T2, T3, T4).\n\nThe control group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy (standard of care).\n\nThe therapy group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy + TrophoTend perilesional injection (TrophoTend will be added on to current standard of care).\n\nAll the screened patients at the baseline visit (T0), after checking the inclusion\u002Fexclusion criteria, will be prospectively included in the clinical investigation, in a 1:1 randomization. Patients will be randomly assigned to the \"control group\" (N=30pts), receiving rehabilitation physiotherapy (standard of care), or to the \"therapy group\" (N=30 pts), receiving Tropho Tend as a add on therapy to the rehabilitation physiotherapy.\n\nTotal duration of Clinical Investigation will be 12 months: 2-4 months for patients screening and enrolment; 1 month of therapy administration (3 perilesional injections 2 weeks apart); 3 months of follow-up; 2-4 months for data analysis and final report\u002Fpaper elaboration.\n\nAt the baseline visit (T0), an ultrasound evaluation (EUS) has to be performed to assess tendon condition. If an EUS evaluation performed within one month from T0 is available, this will be considered acceptable. This first evaluation has to be compared with another EUS performed at the final visit to obtain a qualitative description of the ultrasound appearance of the tendon after the treatment.\n\nPatients' enrolment will take 2-4 months. Tropho Tend will be administrated at T0 (basal visit) at T1 (2 weeks) and at T2 (4 weeks) for a total duration of treatment of 1 month.\n\nFollow-up will be performed at T3 (8 weeks) and T4 (12 weeks= 3 months). End of the clinical investigation will be considered the last visit for the last enrolled patient.\n\nA 40% reduction in mean VAS scores between the \"Tropho Tend therapy group\" and the \"control group\" is considered as reflecting meaningful clinical improvement for the patient.\n\nAt the final visit, the patient has to rate his\u002Fher satisfaction with the treatment using a 5-points Likert scale, where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=highly satisfied.",[99],"Rotator Cuff Tendinopathy",[30,32,101,102,103],"Mastelli","Rotator cuff tendinopathy","Tendinopathy",{"date":105,"type":41},"2026-02-02",{"date":107,"type":41},"2024-12-10",{"date":109,"type":20},"2026-09-30",{"name":47,"class":48},""]