Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis

Официальное название

Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Supportive periodontal and periimplant care
  Periodontal and peri-implant maintenance therapy will be carried out at baseline, 3 and 6-month visit. This session will include the removal of biofilm and calculus on teeth and implants (except those that have just been restored) with an ultrasonic device using a plastic tip ( for implants. and a conventional metal tip ( for teeth. At the end, polishing will be done with a rubber cup Subsequently, patients will be explained that they must continue with their usual oral hygiene technique on the

Первичные конечные точки

• Incidence of peri-implant mucositis [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Affiliation data [Срок оценки: Baseline]
• previous medical history [Срок оценки: Baseline]
• smoking habit [Срок оценки: Baseline]
• Other general data [Срок оценки: Baseline]
• Previous dental history [Срок оценки: Baseline]
• Characteristics of the teeth that have been replaced by implants [Срок оценки: Baseline]
• Surgical procedure [Срок оценки: Baseline]
• Implant characteristics [Срок оценки: Baseline]
• Characteristics of the restorations [Срок оценки: Baseline]
• Mucosal thickness (GM) [Срок оценки: Baseline]
• Mucosal height [Срок оценки: Baseline]
• Modified plaque index (mPI) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Faculty of Dentistry, University Complutense of Madrid (UCM) — Madrid

Идентификаторы

NCT: NCT05356806 · 52-240521

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗