Crown Removal in Non-Surgical Peri-Implantitis Therapy: A Randomized Trial

G. d'Annunzio University

Status: Begins enrollment in 1 month

Conditions: Peri-implantitis

Treatments: Procedure: Non-Surgical Peri-Implant Therapy with Crown; Procedure: Non-Surgical Peri-Implant Therapy without Crown

Study type: Interventional

Funder types: Other

Identifiers

NCT07391202

29012026

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Non-surgical therapy with prosthetic crown removal

Experimental group

Description:

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.

Treatment:

Procedure: Non-Surgical Peri-Implant Therapy without Crown

Non-surgical therapy without prosthetic crown removal

Active Comparator group

Description:

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.

Treatment:

Procedure: Non-Surgical Peri-Implant Therapy with Crown