An interventional study of Non-Surgical Peri-Implant Therapy without Crown and Non-Surgical Peri-Implant Therapy with Crown in Peri-implantitis, sponsored by G. d'Annunzio University. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
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.
322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.
This study's planned enrollment of 36 is close to the median of 40 across 195 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Non-Surgical Peri-Implant Therapy without Crown
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.
Procedure: Non-Surgical Peri-Implant Therapy with 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.
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.
Of 119 non-industry interventional studies with no phase under Peri-Implantitis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 15 months is below that.
Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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