Adjunctive Local Application of Enamel Matrix Derivative or Hyaluronic Acid to Non-surgical Mechanical Treatment of Peri-implantitis: a 12-month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in peri-implant pocket depth
研究概览
简要总结
The aim of the present randomized controlled clinical study is to compare the clinical, radiographic, and patient-centered efficacy of adjunctive application of either enamel matrix derivative (EMD) or hyaluronic acid (HA) gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period.
Therefore, the following question related to the study is raised:
• Does the adjunctive local application of EMD or HA to non-surgical submucosal mechanical treatment of peri-implantitis result in better clinical, radiographic, and patient-centered outcomes compared to non-surgical therapy alone?
A total of 60 patients referred to the Gazi University Department of Periodontology, will be randomly assigned to receive the local application of EMD or HA in combination with non-surgical submucosal mechanical treatment of peri-implantitis or non-surgical therapy alone. Clinical measurements will be recorded at baseline, 3, 6, and 12 months after surgeries. Patient oral health related to the treatment procedures using a written questionnaire [Oral Health Impact Profile (OHIP-14)] and post-treatment pain and overall patient satisfaction about treatment modalities responses will be evaluated prior to treatment and 3, 6, and 12 months following therapy.
详细描述
Peri-implantitis is considered a growing public health problem in implant dentistry due to its higher prevalence and non-linear accelerating progression pattern. Hence, it is imperative to apply effective treatment strategies to manage this pathological condition. The existing evidence has shown unpredictable therapeutic strategies for peri-implantitis. Conventional non-surgical treatment procedures based on the removal of biofilm accumulation and debridement/instrumentation of the implant surface have exhibited limited disease resolution and persistent inflammation following therapy. Therefore, the application of adjunctive chemotherapeutic bioagents may provide greater disease resolution and reduce the need for surgical treatment.
The application of EMD as an adjunctive measure in peri-implantitis treatment has been suggested to provide favorable outcomes by accelerating wound healing, reducing inflammation, having antimicrobial and antiseptic effects, and osteopromotive features. Although some studies exhibited clinical and radiographic efficacy of EMD in augmentative and non-augmentative surgical management of peri-implantitis, there is no study in the available literature analyzing the effects of flapless application of EMD in non-surgical therapy of peri-implantitis. Cross-linked HA, which has recently been recognized as a featured adjuvant chemotherapeutic bioagent, has also been shown to have beneficial effects in periodontal wound healing and soft and hard tissue regeneration. The use of high-molecular-weight HA has been demonstrated to alter bacterial colonization in the advanced stage of peri-implantitis. However, there is limited evidence about the therapeutic effect of cross-linked HA in peri-implantitis management.
The hypothesis of the study is that the application of EMD and cross-linked HA adjunct to non-surgical therapy could lead to superior outcomes compared to non-surgical therapy alone in peri-implantitis treatment. The null-hypothesis (H0) is that no statistically significant difference in terms of the mean change of probing depth (PD) values after 12 months would be detected among all the study groups.
The aim of the present randomized controlled clinical study is to compare the clinical, radiographic, and patient-centered efficacy of adjunctive application of either enamel matrix derivative (EMD) or hyaluronic acid (HA) gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period.
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 (Investigator)
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
- •Systemically healthy and ≥18 years of age,
- •Implants with an SLA® or SLActive® surface (Straumann Dental Implant System, Institute Straumann AG) have been in function for more than 1 year,
- •Implant-supported prostheses accessible for self-performed plaque control and submarginal instrumentation,
- •Absence of implant mobility.
排除标准
- •Full-mouth plaque score (FMPS) > 20%
- •Full-mouth bleeding score (FMBS) > 20%
- •Cigarette smoking > 10 cig./day,
- •Diagnosed with active periodontal disease,
- •Having acute or chronic medical conditions or undergoing medications, such as intravenous amino-bisphosphonates, immunosuppressive drugs, and chemotherapy, that could interfere with the treatment outcome,
- •Receiving antibiotic treatment in the previous 3 months.
结局指标
主要结局
Change in peri-implant pocket depth
时间窗: 12 months after the treatment
Peri-implant pocket depth (PPD) values will be measured at six sites of each implant. The mean PPD change will be calculated as the difference between the 12-month follow-up PPD relative to the baseline PPD.
次要结局
- Treatment success (%)(12 months after the treatment)
- Disease resolution (%)(12 months after the treatment)
- Oral Health Impact Profile 14(12 months after the treatment)
- Post-treatment pain(12 months after the treatment)
研究者
Sıla Çağrı İşler
Associate Professor
Gazi University