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NCT Number: NCT07391202

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

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chieti, 66100, Italy

Location status: Recruiting

Location contact

Matteo Serroni, DDS

CONTACT

[email protected]

08713554158

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Peri-implant probing depth (PIPD)

    Time frame: From enrollment to the end of treatment at 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Paolantonio, DDS, MD

CONTACT

[email protected]

+3908713554158

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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