Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- G. d'Annunzio University
- Enrollment
- 36
- Primary Endpoint
- Peri-implant probing depth (PIPD)
Overview
Brief Summary
The aim of this single-blind, randomized controlled clinical trial is to evaluate whether removal of the prosthetic crown influences the clinical effectiveness of non-surgical mechanical therapy in implants affected by peri-implantitis.
The study is designed to compare changes in several clinical and radiographic parameters between baseline and follow-up examinations at 3, 6, and 12 months. The primary outcome measure will be the mean peri-implant probing depth (PIPD). Secondary outcomes will include changes in gingival recession (REC), radiographic marginal bone level (MBL), modified bleeding index (mBI), and additional patient-related variables.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Non-surgical therapy with prosthetic crown removal
Implants allocated to this group will receive non-surgical peri-implant therapy after temporary removal of the prosthetic crown. The crown will be unscrewed before treatment to allow direct access and full visibility of the implant surface and peri-implant tissues. Mechanical debridement will then be performed under local anesthesia using sonic and ultrasonic devices with dedicated thin tips and Gracey curettes, according to the EFP S3-level clinical practice guidelines. After completion of debridement and biofilm removal, the prosthetic crown will be reinstalled. Patients will receive oral hygiene instructions and reinforcement.
Intervention: Non-Surgical Peri-Implant Therapy without Crown (Procedure)
Non-surgical therapy without prosthetic crown removal
Implants allocated to this group will receive non-surgical peri-implant therapy with the prosthetic crown left in place. Mechanical debridement will be performed under local anesthesia using the same instruments and protocol as in the test group (sonic scaler, ultrasonic devices, and Gracey curettes), but with access limited by the presence of the restoration. Professional oral hygiene instructions and reinforcement will also be provided.
Intervention: Non-Surgical Peri-Implant Therapy with Crown (Procedure)
Outcomes
Primary Outcomes
Peri-implant probing depth (PIPD)
Time Frame: From enrollment to the end of treatment at 1 year
Change in mean peri-implant probing depth (PIPD) at the implant level (measured at 6 sites per implant) from baseline to 3, 6, and 12 months after crown removal.
Secondary Outcomes
No secondary outcomes reported
Investigators
Michele Paolantonio
Full Professor
G. d'Annunzio University