Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07391202

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

Led by G. d'Annunzio University · Updated on 2026-05-07

36

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how removing the prosthetic crown affects non-surgical mechanical treatment for implants with peri-implantitis. The goal is to compare clinical and radiographic changes at baseline and after 3, 6, and 12 months. The main measure is the average probing depth around the implant, with additional focus on gum recession, bone levels, bleeding scores, and patient factors. The study has two groups: one where the prosthetic crown is temporarily removed before treatment to allow better access for cleaning, and another where the crown remains in place during therapy. Both groups receive mechanical debridement under local anesthesia using sonic and ultrasonic devices with thin tips and Gracey curettes, following clinical guidelines. After cleaning, crowns are replaced in the removal group, and all patients get oral hygiene instructions. Participants will be assessed through clinical exams and radiographic imaging at specified intervals up to one year. Researchers will measure gum and bone changes, bleeding, and implant pocket depth to evaluate treatment effects. Safety and adherence will be monitored throughout, with a total study duration of 12 months from enrollment to final evaluation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with at least one implant diagnosed with peri-implantitis
  • Patients with a removable crown on the implant affected by peri-implantitis
  • 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
Not Eligible

You will not qualify if you...

  • Full-Mouth Plaque Score (FMPS) greater than 30% at the time of non-surgical therapy
  • Pregnant or breastfeeding women
  • Relevant medical history that could affect the outcome of therapy, as judged by the clinician
  • Smoking more than 10 cigarettes per day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 1 year

Participants receive non-surgical peri-implant therapy with or without temporary removal of the prosthetic crown. Mechanical cleaning of the peri-implant tissues is performed under local anesthesia using sonic and ultrasonic devices and curettes. Oral hygiene instructions and reinforcement are provided.

Trial Site Locations

Total: 1 location

1

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

Chieti, Chieti, Italy, 66100

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Research Team

M

Michele Paolantonio, DDS, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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