Non-surgical treatment for peri-implantitis using chitosan and tetracycline
Non Surgical Treatment of Peri-implantitis Using an Oscillating Chitosan Brush With Adjunctive Tetracycline Slurry: A Randomized Clinical Trial
This study is testing a non-surgical treatment for mild peri-implantitis to see if adding tetracycline helps improve gum health around dental implants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT06695559 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a non-surgical treatment for mild peri-implantitis using Labrida Bioclean, with and without the addition of tetracycline slurry. It is a prospective, randomized, parallel arm, blind trial that will compare clinical and radiographic outcomes, focusing on probing pocket depth reduction as the primary outcome. Secondary outcomes include clinical attachment level, radiographic bone fill, and other clinical indicators of peri-implant health. The study will involve patients with specific criteria related to peri-implant bone loss and pocket depth.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with mild peri-implantitis characterized by bone loss of 3-6 mm and probing pocket depths of 6 mm or deeper.
Not a fit: Patients with severe peri-implant bone loss greater than 6 mm or those with specific technical complications related to their implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less invasive option for managing peri-implantitis, potentially improving implant longevity.
How similar studies have performed: Previous studies have shown varying success with non-surgical treatments for peri-implantitis, but this specific approach using chitosan and tetracycline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Peri-implantitis defined as periimplant bone loss ≥ 3 mm on periapical x-rays distally, mesially or both and with Probing Pocket Depth (PPD) ≥6 mm. * Peri-implantitis as defined above on an implant that has been in function for more than 12 months prior to study start. * Above 18 years of age. * Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologists classification I and II). * Had full-mouth plaque scores \< 20% prior to final inclusion. * Had at least one implant with a loading time of ≥ 12 months prior to baseline. * Signed Informed Consent obtained prior to start. * Psychological appropriateness * Consent to complete all follow-up visits. * Patients diagnosed with periodontal disease must have undergone causative treatment and be re-evaluated Exclusion Criteria: * Peri-implant bone loss \> 6 mm on periapical x-rays * Cemented supraconstructions and/or screw retained supraconstructions that for technical reasons makes it impossible to access implant for clinical measurements. * Technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion. * Mobile implant. * Implants previously treated for peri-implantitis with grafting materials. * Receiving medications known to induce mucosal hyperplasia. * Uncontrolled diabetes (HbA1c \> 7). * Receiving systemic antibiotics \< 3 months prior to inclusion. * Pregnant or lactating. * Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk. * Presence of psychological characteristics, such as inappropriate attitude or motivation, which will influence treatment execution and treatment outcome. * Unwillingness to undergo treatment. * If, in the medical opinion of the therapist, conditions are such that dental implants are deemed failing. * Ongoing or previous radiotherapy to the head-neck region. * Ongoing or previous chemotherapy. * Systemic long-term corticosteroid treatment. * Patients medicating with warfarin products or similar
Where this trial is running
Thessaloniki
- Aristotle University of Thessaloniki — Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Eleftherios Mitsopoulos
- Email: lefterismt95@gmail.com
- Phone: 6983415774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.