Effectiveness of Interproximal Cleaning Devices for Biofilm Removal Around Posterior Single Implants With Peri-Implant Mucositis

Официальное название

Efficacy of Biofilm Removal of Different Interproximal Oral Hygiene Devices Around Posterior Single Implants in Peri-Implant Mucositis: A Randomized Clinical Trial

Обзор

This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis. Peri-implant mucositis is a reversible inflammatory condition of the peri-implant soft tissues caused primarily by bacterial biofilm accumulation. Effective plaque control is essential for the prevention of disease progression to peri-implantitis. However, there is limited clinical evidence regarding the comparative effectiveness of different interproximal oral hygiene devices in implant-supported sites. A total of approximately 75 patients with posterior single implants and peri-implant mucositis will be recruited. Participants will be randomly allocated to one of the study groups, each using a specific interproximal oral hygiene device as part of their daily oral hygiene regimen. All participants will receive standardized oral hygiene instructions at baseline. Clinical parameters related to peri-implant inflammation and plaque accumulation will be assessed at baseline and at follow-up visits at 1, 3, and 6 months. The primary outcome is the reduction of peri-implant biofilm accumulation. Secondary outcomes include changes in clinical inflammatory parameters around the implants. The results of this study are expected to provide clinically relevant evidence to support evidence-based recommendations for interproximal oral hygiene in patients with dental implants affected by peri-implant mucositis.

Вмешательства

• Устройство Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (inter
  Participants will receive a structured oral hygiene intervention using interproximal oral hygiene devices specifically designed for use around posterior single implants diagnosed with peri-implant mucositis. The intervention consists of standardized instruction and supervised use of the assigned interproximal device according to manufacturer recommendations and a predefined clinical protocol. The device will be used by participants for daily interproximal plaque control around the implant site t

Первичные конечные точки

• Change in peri-implant biofilm accumulation [Срок оценки: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention]
• Change in peri-implant biofilm accumulation [Срок оценки: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention]

Вторичные конечные точки (1)

• Change in peri-implant probing pocket depth [Срок оценки: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention]

Критерии участия

Критерии включения

Adults aged ≥18 years. Presence of at least one posterior single dental implant in function for ≥12 months.

Diagnosis of peri-implant mucositis, defined as bleeding on probing with probing depths ≤5 mm and no radiographic bone loss beyond initial remodeling.

Good general health (ASA I-II). Ability and willingness to comply with study procedures and follow-up visits. Provision of written informed consent.

Критерии исключения

Diagnosis of peri-implantitis (radiographic bone loss beyond initial remodeling).

Uncontrolled systemic diseases affecting periodontal or peri-implant health (e.g., uncontrolled diabetes mellitus).

Use of systemic antibiotics or anti-inflammatory drugs within the previous 3 months.

Current pregnancy or lactation. Current smoker of >10 cigarettes/day. History of periodontal therapy or professional implant maintenance within the previous 3 months.

Use of medications known to affect bone metabolism (e.g., bisphosphonates). Inability to perform adequate oral hygiene or to attend scheduled study visits.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07393828 · PER-ECL-2025-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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