Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peri-implant Mucositis
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 277
- Locations
- 1
- Primary Endpoint
- Incidence of peri-implant mucositis
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of peri-implant mucositis
Time Frame: 12 months
The risk of developing PM (patient with at least one implant who has bleeding on probing, with or without suppuration and without progressive radiographic bone loss) during a follow-up period of 12 months.
Secondary Outcomes
- previous medical history(Baseline)
- Affiliation data(Baseline)
- Width of the mucosa:(12 months)
- smoking habit(Baseline)
- Implant characteristics(Baseline)
- Modified plaque index (mPI)(12 months)
- Implant-Abutment Gap(12 months)
- Other general data(Baseline)
- Mucosal height(Baseline)
- Modified sulcus bleeding Index (mBI)(12 months)
- Microbiological samples(12 months)
- Previous dental history(Baseline)
- Characteristics of the teeth that have been replaced by implants(Baseline)
- Surgical procedure(Baseline)
- Bleeding on probing (BOP)(12 months)
- Suppuration on probing (Sup):(12 months)
- Probing depth (PS)(12 months)
- Characteristics of the restorations(Baseline)
- Mucosal thickness (GM)(Baseline)
- Crown length (CL):(12 months)
- full-mouth periodontal clinical parameters(12 months)
- Radiographic bone level(12 months)
- Emergence angle and profile (concave/straight or convex) of restorations(12 months)
- Patient reported outcomes(12 months)