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Recruiting NCT07391202

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

No phase Interventional Peri-implantitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Surgical Peri-Implant Therapy without Crown, Non-Surgical Peri-Implant Therapy with Crown.
Who it may be relevant to
Registry conditions: Peri-implantitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure 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 disrup
  • Procedure 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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Dental Clinic, Department of Innovative Technologies in Medicine and Dentistry, 'G. D'Annu — Chieti

Identifiers

NCT: NCT07391202 · 29012026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗