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Clinical Trials in Italy / NCT07391202
Recruiting Not applicable

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

NCT07391202 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-04-20
Last updated
2026-05-07

Condition(s) studied

Peri-implantitis

Investigational drug(s) / intervention(s)

Non-Surgical Peri-Implant Therapy without CrownNon-Surgical Peri-Implant Therapy with Crown

Non-Surgical Peri-Implant Therapy without Crown: In this group, the prosthetic crown will be temporarily removed before treatment to allow direct and complete access to the peri-implant tissues and implant surface. After local anesthesia, a thorough mechanical debridement will be performed up to the bottom of the peri-implant pocket using sonic scalers, piezoelectric/ultrasonic devices with dedicated thin tips, and Gracey curettes. The absence of the crown enables improved visualization, more effective instrumentation, and more accurate disruption of the submucosal biofilm. At the end of the procedure, the prosthetic crown will be repositioned. Standardized oral hygiene instructions and motivation will be provided. This intervention aims to maximize cleaning efficacy by eliminating prosthetic-related access limitations.

Non-Surgical Peri-Implant Therapy with Crown: In this group, non-surgical mechanical therapy will be carried out with the prosthetic crown left in place. After local anesthesia, debridement of the peri-implant pocket will be performed using the same instruments and protocol as in the test group, including sonic scalers, ultrasonic devices with thin tips, and Gracey curettes. The presence of the crown limits access to some peri-implant areas and reflects routine clinical practice. Patients will receive standardized oral hygiene instructions and reinforcement. This intervention represents the conventional non-surgical management of peri-implantitis without removal of the restoration

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dental Clinic, Department of Innovative Technologies in Medicine and Dentistry, 'G. D'Annunzio' University of Chieti-Pescara Chieti Chieti Recruiting

More G. d'Annunzio University trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07391202 on ClinicalTrials.gov ↗ ← All trials in Italy