Non-surgical H42 treatment for peri-implant pockets
Official title: Non-surgical Treatment of Peri-implant Pockets With H42
Run by Bioteck S.p.A. · NCT07680491 · Data updated 2026-11-12
This study tests whether H42 can help heal peri-implant pockets compared with no-H42 care in adults with 6–8 mm pockets.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 25 Years to 65 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Bioteck S.p.A. Industry-sponsored |
| Locations | 1 site (Seville) |
| Status | Recruiting |
| Started | December 3, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07680491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 25–65 with 1–5 peri-implant pockets measuring 6–8 mm.
✕Probably not a fit
Patients with higher smoking burden, bleeding disorders, anticoagulant use, recent gum health procedures, or infectious diseases may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling 56 adults with peri-implant pockets of 6–8 mm. Half receive the non-surgical H42 treatment and half serve as controls to monitor soft tissue healing and changes in bone level over three months. Outcomes include pocket depth, plaque index, gingival inflammation, pain, and infection status at multiple time points, plus a five-point tissue assessment and radiographic bone measurements. Safety is tracked through adverse events throughout the study. Data will be collected at baseline, and at 1, 3 months, with interim checks at 7–21 days as applicable.
Why it matters
Potential benefit: If successful, patients receiving H42 could experience improved pocket healing and tissue health around affected implants.
How similar studies have gone: Previous studies with similar non-surgical approaches have shown variable but encouraging improvements in peri-implant soft tissue outcomes; this study adds a controlled comparison in a defined 3-month window.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Faculty of Dentistry, University of Seville
Seville, Spain Recruiting
Study contacts
- Study coordinator: Marco Morroni, PhD
- Email: m.morroni@bioteck.com
- Phone: 0444 289366
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.