Clinical trial NCT05356806: Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis
Official title: Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peri-implant Mucositis
Keywords: peri-implant mucositis
incidence
biofilm
periodontitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Periodoncia (SEPA)
name: Dentaid SL
First posted: 2022-05-02
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 in the same center

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.

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.

Primary outcomes:
measure: Incidence of peri-implant mucositis
timeFrame: 12 months
Secondary outcomes:
measure: Affiliation data
timeFrame: Baseline
measure: previous medical history
timeFrame: Baseline
measure: smoking habit
timeFrame: Baseline
measure: Other general data
timeFrame: Baseline
measure: Previous dental history
timeFrame: Baseline
measure: Characteristics of the teeth that have been replaced by implants
timeFrame: Baseline
measure: Surgical procedure
timeFrame: Baseline
measure: Implant characteristics
timeFrame: Baseline
measure: Characteristics of the restorations
timeFrame: Baseline
measure: Mucosal thickness (GM)
timeFrame: Baseline
measure: Mucosal height
timeFrame: Baseline
measure: Modified plaque index (mPI)
timeFrame: Baseline
measure: Modified plaque index (mPI)
timeFrame: 6 months
measure: Modified plaque index (mPI)
timeFrame: 12 months
measure: Modified sulcus bleeding Index (mBI)
timeFrame: Baseline
measure: Modified sulcus bleeding Index (mBI)
timeFrame: 6 months
measure: Modified sulcus bleeding Index (mBI)
timeFrame: 12 months
measure: Bleeding on probing (BOP)
timeFrame: Baseline
measure: Bleeding on probing (BOP)
timeFrame: 6 months
measure: Bleeding on probing (BOP)
timeFrame: 12 months
measure: Suppuration on probing (Sup):
timeFrame: Baseline
measure: Suppuration on probing (Sup):
timeFrame: 6 months
measure: Suppuration on probing (Sup):
timeFrame: 12 months
measure: Probing depth (PS)
timeFrame: Baseline
measure: Probing depth (PS)
timeFrame: 6 months
measure: Probing depth (PS)
timeFrame: 12 months
measure: Crown length (CL):
timeFrame: Baseline
measure: Crown length (CL):
timeFrame: 6 months
measure: Crown length (CL):
timeFrame: 12 months
measure: Width of the mucosa:
timeFrame: Baseline
measure: Width of the mucosa:
timeFrame: 6 months
measure: Width of the mucosa:
timeFrame: 12 months
measure: full-mouth periodontal clinical parameters
timeFrame: Baseline
measure: full-mouth periodontal clinical parameters
timeFrame: 6 months
measure: full-mouth periodontal clinical parameters
timeFrame: 12 months
measure: Radiographic bone level
timeFrame: Baseline
measure: Radiographic bone level
timeFrame: 6 months
measure: Radiographic bone level
timeFrame: 12 months
measure: Implant-Abutment Gap
timeFrame: Baseline
measure: Implant-Abutment Gap
timeFrame: 6 months
measure: Implant-Abutment Gap
timeFrame: 12 months
measure: Emergence angle and profile (concave/straight or convex) of restorations
timeFrame: Baseline
measure: Emergence angle and profile (concave/straight or convex) of restorations
timeFrame: 6 months
measure: Emergence angle and profile (concave/straight or convex) of restorations
timeFrame: 12 months
measure: Patient reported outcomes
timeFrame: Baseline
measure: Patient reported outcomes
timeFrame: 6 months
measure: Patient reported outcomes
timeFrame: 12 months
measure: Microbiological samples
timeFrame: Baseline
measure: Microbiological samples
timeFrame: 6 months
measure: Microbiological samples
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, University Complutense of Madrid (UCM)
Study officials:
affiliation: Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
name: Elena Figuero, Prof.
role: PRINCIPAL_INVESTIGATOR
References: