Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis

Официальное название

Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis

Обзор

To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.

Подробное описание

Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.

Вмешательства

• Другое Placebo gel
  Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo gel
• Другое Enamel Matrix Proteins Derivative
  Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of non-surgical treatment plus Enamel Matrix Proteins Derivative

Первичные конечные точки

• Bleeding on probing (BOP) changes [Срок оценки: 6-months]

Вторичные конечные точки (6)

• Probing pocket depth (PPD) changes [Срок оценки: 6-months]
• Full mouth plaque score (FMPS) % changes [Срок оценки: 6-months]
• Full mouth bleeding score (FMBS) % changes [Срок оценки: 6-months]
• Plaque at implant sites according to modified gingival index (mGI) changes score [Срок оценки: 6-months]
• Plaque at implant sites according to modified plaque index (mPlI) changes score [Срок оценки: 6-months]
• Patient-Reported Outcome Measures (PROMs) [Срок оценки: 6-months]

Критерии участия

Критерии включения

• age ≥18 years old;
• implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),
• implants placed in both maxilla and mandible
• patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm
• presence at least of 2 mm of keratinized mucosa (KT) at implant sites

Критерии исключения

• presence of systemic diseases;
• pregnancy or lactating;
• use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;
• implants with modified (i.e., micro-rough) necks;
• interproximal open contacts between implant restoration and adjacent teeth; peri-implantitis (Berglundh et al., 2018)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Policlinico G. Rodolico — Catania

Идентификаторы

NCT: NCT06725095 · 2024-3306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗