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

ConditionPeri-implantitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorG. d'Annunzio University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Non-Surgical Peri-Implant Therapy without Crown
Procedure/Surgery
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
Procedure/Surgery
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

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Non-surgical therapy with prosthetic crown removalExperimental treatment 1 intervention

Group B: Non-surgical therapy without prosthetic crown removalActive comparator 1 intervention

Trial outcomes

Primary outcomes

Peri-implant probing depth (PIPD)

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.

Time frame

From enrollment to the end of treatment at 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

G. d'Annunzio University

Lead sponsor

Source ClinicalTrials.gov

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