Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Bleeding on probing (BOP) changes
研究概览
简要总结
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.
详细描述
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Bleeding on probing (BOP) changes
时间窗: 6-months
The number of implants presenting with complete absence of BOP or implants with limited extent of BOP (≤1 spot/implant-the presence of a single spot)
次要结局
- Probing pocket depth (PPD) changes(6-months)
- Full mouth plaque score (FMPS) % changes(6-months)
- Full mouth bleeding score (FMBS) % changes(6-months)
- Plaque at implant sites according to modified gingival index (mGI) changes score(6-months)
- Plaque at implant sites according to modified plaque index (mPlI) changes score(6-months)
- Patient-Reported Outcome Measures (PROMs)(6-months)
研究者
Gaetano Isola
Associate Professor
University of Catania