Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis (PiM_Inc)

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Peri-implant Mucositis

Treatments: Other: Supportive periodontal and periimplant care

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05356806

52-240521

Details and patient eligibility

About

the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.

Full description

Introduction: Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.

Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.

Enrollment: 277 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years of age, able to comply with the protocol and comply with the established visits.
• Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).
• Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis [individual, partial or complete], hybrid or overdenture).
• Physical or mental conditions that make it possible to perform appropiate oral hygiene

Exclusion criteria

• Patients with untreated periodontitis.
• Totally edentulous patients.
• Patients with peri-implant diseases.
• Pregnant or in lactating-period patients.
• Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).
• Patients who have taken antibiotics in the last month.

Trial design

277 participants in 1 patient group

One

Description:

Patients with treated periodontitis who have had dental implants placed at the Periodontics Specialist Clinic of the UCM School of Dentistry, and are going to be rehabilitated.

Treatment:

Other: Supportive periodontal and periimplant care