NCT07680491 Non-surgical Treatment of Peri-implant Pockets With H42
| NCT ID | NCT07680491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bioteck S.p.A. |
| Condition | Peri-implantitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 56 participants in total. It began in 2025-12-03 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes. Clinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.
Eligibility Criteria
Inclusion Criteria: * Men or women with age ≥ 25 and ≤ 65 years. * Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm. * Each subject can have from 1 to 5 defects. * Subjects willing to provide signed informed consent to clinical investigation participation. Exclusion Criteria: * Use of aspirin and antiplatelet agents a week before treatment. * Subjects smokers ≥ 10 cigarettes per day. * Subjects presenting current or previous bleeding disorders. * Subjects taking or having indications for anticoagulant therapy. * Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery. * Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus. * Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07680491 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Peri-implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07680491 currently recruiting?
Yes, NCT07680491 is actively recruiting participants. Contact the research team at m.morroni@bioteck.com for enrollment information.
Where is the NCT07680491 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT07680491 clinical trial?
NCT07680491 is sponsored by Bioteck S.p.A.. The trial plans to enroll 56 participants.