Removing the crown during non-surgical treatment for peri-implantitis.
Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial
This study will test whether taking off the prosthetic crown from an affected implant helps non-surgical cleaning work better for people with peri-implantitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | G. d'Annunzio University Academic / other |
| Locations | 1 site (Chieti, Chieti) |
| Trial ID | NCT07391202 on ClinicalTrials.gov |
What this trial studies
This single-blind randomized trial will compare non-surgical mechanical therapy performed with the crown left in place versus after crown removal for implants affected by peri-implantitis. Clinical and radiographic measures will be collected at baseline and at 3, 6, and 12 months, with mean peri-implant probing depth as the primary outcome. Secondary outcomes include gingival recession, radiographic marginal bone level, modified bleeding index, and patient-related variables. Eligible participants are adults with at least one implant meeting peri-implantitis criteria and a removable crown, with exclusions for poor oral hygiene, recent antibiotics, heavy smoking, pregnancy, or other conditions affecting healing.
Who should consider this trial
Good fit: Ideal candidates are adults who have at least one implant with peri-implantitis and a removable crown, have not had non-surgical peri-implant therapy in the past 6 months or systemic antibiotics in the past 3 months, maintain good oral hygiene (FMPS ≤ 30%), are not pregnant, and do not smoke more than 10 cigarettes per day.
Not a fit: Patients unlikely to benefit include those without a removable crown, with poor oral hygiene (FMPS > 30%), heavy smokers (>10 cigarettes/day), pregnant or breastfeeding women, recent antibiotic recipients, or those with medical conditions that impair healing.
Why it matters
Potential benefit: If successful, removing the crown could lead to better pocket depth reduction and preserve supporting bone, possibly reducing the need for further invasive treatment.
How similar studies have performed: This specific question is relatively novel and prior data are limited, while existing non-surgical peri-implantitis studies have shown mixed and often modest long-term results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with at least one implant diagnosed with peri-implantitis (Berglundh et al., 2018); * Patients with a crown on the implant affected by peri-implantitis that is removable; * Patients who have not received non-surgical peri-implant therapy in the previous 6 months; * Patients who have not taken systemic antibiotic therapy in the previous 3 months. Exclusion Criteria: * Full-Mouth Plaque Score (FMPS) \> 30% at the time of non-surgical therapy; * Pregnant or breastfeeding women; * Relevant medical history, in the opinion of the examining clinician, that could affect the outcome of non-surgical peri-implant therapy; * Smoking patients consuming \> 10 cigarettes/day.
Where this trial is running
Chieti, Chieti
- Dental Clinic, Department of Innovative Technologies in Medicine and Dentistry, 'G. D'Annunzio' University of Chieti-Pescara — Chieti, Chieti, Italy (Recruiting)
Study contacts
- Study coordinator: Michele Paolantonio, DDS, MD
- Email: michelapolantonio@gmail.com
- Phone: +3908713554158
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.