Investigating the effects of peri-implantitis and its treatment
Local and Systemic Effects of Peri-implantitis and Its Treatment (LASSO). A Randomised Controlled Clinical Trial
This study is testing how peri-implantitis affects people with dental implants and whether different treatments can help improve their condition over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eastman Dental Insitute and Hospital Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05964127 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of peri-implantitis, an inflammatory condition affecting the tissues around dental implants, and its treatment on both local and systemic levels. It consists of two parts: an observational study comparing cases of peri-implantitis with controls, followed by an interventional study where participants with peri-implantitis will receive treatment and be monitored for six months. The research will utilize clinical and biological parameters to assess the outcomes of the interventions, which include the use of an air flow device, hand instruments, and access flap surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have at least one dental implant with peri-implantitis.
Not a fit: Patients with uncontrolled systemic medical conditions, active periodontitis, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from peri-implantitis, enhancing the longevity and health of dental implants.
How similar studies have performed: While there is limited understanding of peri-implantitis, similar studies on periodontal disease have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age and in good general health * A minimum of 20 teeth * Participants must have at least one implant in situ with peri-implantitis as per its case definition * Must voluntarily agree to sign the consent form Exclusion Criteria: * Currently on any weight reduction program * History of diabetes * Uncontrolled or currently undergoing treatment for systemic medical conditions * Chronic treatment (defined as 2 weeks or more) of antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline assessment * Taking statins drugs * History of alcohol or drug abuse * Self-reported pregnancy or breastfeeding * Patients who have active periodontitis as per its case definition and/or have had treatment for periodontitis within the last 1 year
Where this trial is running
London
- University College London — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jeanie Suvan
- Email: j.suvan@ucl.ac.uk
- Phone: +442034561108
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.