Efficacy of Biofilm Removal of Different Interproximal Oral Hygiene Devices Around Posterior Single Implants in Peri-Implant Mucositis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Change in peri-implant biofilm accumulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Interdental Brush Group
Participants use interdental brushes for interproximal plaque control around posterior implants.
干预措施: 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 (Device)
Oral Irrigator Group
Participants use an oral irrigator for interproximal plaque control around posterior implants.
干预措施: 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 (Device)
Superfloss Group
Participants use Superfloss for interproximal plaque control around posterior implants.
干预措施: 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 (Device)
结局指标
主要结局
Change in peri-implant biofilm accumulation
时间窗: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
Change in interproximal peri-implant biofilm accumulation measured using a validated plaque index (e.g., Modified Plaque Index) at posterior single implants.
次要结局
- Change in peri-implant probing pocket depth(Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention)