Incidence of gum inflammation around dental implants in patients with treated gum disease
Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.
This study looks at how often gum inflammation happens around dental implants in people who have had gum disease treatment to see what might increase the risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 277 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05356806 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the incidence of peri-implant mucositis in patients who have undergone treatment for periodontitis and are currently in periodontal maintenance. It will involve a 12-month follow-up period where clinical records, radiographic data, and microbiological samples will be collected from patients with osseointegrated dental implants. The study seeks to identify risk indicators associated with the development of peri-implant mucositis, which is an inflammatory condition caused by bacterial biofilm accumulation around dental implants. The findings may help improve maintenance protocols for patients with dental implants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with treated periodontitis who are currently in periodontal maintenance and have dental implants awaiting prosthodontic rehabilitation.
Not a fit: Patients with untreated periodontitis, those who are totally edentulous, or those with existing peri-implant diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for preventing peri-implant mucositis in patients with a history of periodontitis.
How similar studies have performed: While studies on peri-implant mucositis exist, this specific observational approach focusing on treated periodontitis patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years of age, able to comply with the protocol and comply with the established visits. * Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020). * Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis \[individual, partial or complete\], hybrid or overdenture). * Physical or mental conditions that make it possible to perform appropiate oral hygiene Exclusion Criteria: * Patients with untreated periodontitis. * Totally edentulous patients. * Patients with peri-implant diseases. * Pregnant or in lactating-period patients. * Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories). * Patients who have taken antibiotics in the last month.
Where this trial is running
Madrid
- Faculty of Dentistry, University Complutense of Madrid (UCM) — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Elena Figuero, Prof. — Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
- Study coordinator: Elena F Figuero, Prof.
- Email: elfiguer@ucm.es
- Phone: 0034913942186
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.