Crown Removal in Non-Surgical Peri-Implantitis Therapy: A Randomized Trial
ConditionPeri-implantitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorG. d'Annunzio University
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Non-Surgical Peri-Implant Therapy without Crown
- Non-Surgical Peri-Implant Therapy with Crown
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov