Treatment for gum inflammation around dental implants using special gels
Treatment of Peri-implant Mucositis by Non-surgical Debridement and Adjunctive Application of a Combination of Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
This study is testing if using a special gel along with a cleaning treatment can help reduce gum inflammation around dental implants better than just the cleaning treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 2 sites (Budapest, HU and 1 other locations) |
| Trial ID | NCT05926297 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a sodium hypochlorite gel combined with a hyaluronic acid gel as an adjunct to Non-Surgical Mechanical Debridement (NSMD) for treating peri-implant mucositis. Patients will be randomly assigned to either a test group receiving both gels and NSMD or a control group receiving only NSMD. Clinical parameters will be recorded before and after a 6-month follow-up to assess the treatment outcomes. The study aims to provide insights into improving the management of mucositis around dental implants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with at least one dental implant exhibiting signs of mucositis.
Not a fit: Patients with uncontrolled diabetes, cancer, or those undergoing prolonged antibiotic or anti-inflammatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance healing and reduce inflammation for patients with peri-implant mucositis.
How similar studies have performed: While similar approaches have been explored, this specific combination of treatments is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Non-smokers and smokers ( ≤ 10 cigarettes/day); * Presence of at least 1 implant in mucositis, clinically and radiographically detected; * The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed. Exclusion Criteria: * Cancer patients; * Uncontrolled diabetic patients; * Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; * Pregnant or breastfeeding patients; * Implants that support mobile prosthetic products; * Implants in peri-implantitis, detected clinically and radiographically.
Where this trial is running
Budapest, HU and 1 other locations
- Semmelweis University — Budapest, Hu, Hungary (Recruiting)
- University of Naples Federico II — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Ramaglia — Federico II University
- Study coordinator: Luca Ramaglia
- Email: luca.ramaglia@unina.it
- Phone: +393476912911
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.