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

Sponsor
G. d'Annunzio University
Study ID
NCT07391202
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Non-Surgical Peri-Implant Therapy without Crown — PROCEDURE
    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
    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 Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Peri-implant probing depth (PIPD) [ Time Frame: From enrollment to the end of treatment at 1 year ]

Central Contacts

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