Evaluation of the Effect of Erbium, Chromium:Yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Application on Peri-Implant Crevicular Fluid RANKL and OPG Levels in the Treatment of Peri-implantitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)
研究概览
简要总结
In the present study, investigators, aimed to evaluate the effect of erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser application combined with mechanical debridement (MD) on clinical parameters and biochemical parameters such as receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in patients with peri-implant diseases.
详细描述
Peri-implantitis is a plaque-associated which involves the tissues around dental implants characterized by inflammation and progressive loss of the supporting alveolar bone. According to a meta-analysis and systematic review, the prevalence of peri-implantitis is about 22%. Biofilm, poor plaque control, and poor dental care after dental implant are implicated in the etiology of disease.
Surface decontamination of the implant is the cornerstone of peri-implantitis treatment. However, there is no sufficient evidence to demonstrate the superiority of a specific decontamination protocol in the literature. Nevertheless, a review recommended the potential use of laser-assisted procedures as an adjunct to mechanical instrumentation and implant detoxification in both non-surgical and regenerative interventions for the treatment of peri-implant diseases. Several studies have examined the role of a variety of laser types in both periodontal and peri-implant treatments and laser application has been shown to play a central role in wound healing and tissue regeneration.
Erbium lasers such as erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) use mid-infrared wavelengths which are highly absorbed by water and hydroxyapatite crystals and minerals. In a recent in vitro study, Er,Cr:YSGG laser has been shown to be a safe method in the treatment of peri-implantitis with the dual wavelength protocol. In the literature, there is a limited number of studies using Er,Cr:YSGG laser in the treatment of peri-implantitis in the in vivo setting. Although limited, favorable results have been described in a case report with 18-month follow-up, case reports of including 11 patients, and randomized-controlled clinical studies. Taken together, Er,Cr:YSGG laser seems to be an effective treatment modality in reducing clinical symptoms of peri-implantitis.
The detection of specific biomarkers in the peri-implant crevicular fluid (PICF) is promising to objectively evaluate peri-implant inflammation at baseline and assess treatment efficacy. Biomarkers are host response molecules which reflect a biological state and help to distinguish healthy from diseased tissues or to evaluate disease and its severity.
Recent discoveries regarding the receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) receptor activator that induce and inhibit osteoclast differentiation have shown that both markers play a role in the molecular network of peri-implant bone resorption. The RANKL is a member of tumor necrosis factor (TNF) superfamily which interacts on osteoclastogenesis. It is secreted by osteoblasts, fibroblasts, and activated T cells and is associated with RANK as a surface-bound molecule which stimulates osteoclast activity. On the other hand, OPG is a soluble decoy receptor for RANKL and expressed by osteoblasts. It also inhibits the osteoclast differentiation and prevents the interaction between RANKL and RANK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •bone loss as evidenced by X-ray and inflammatory symptoms in the soft tissue, bleeding and/or suppuration around the implant compatible with peri-implantitis (each patient had a single dental implant or the implant in the deepest pathological pocket not requiring surgical intervention was chosen in case of peri-implantitis in multiple implants);
- •radiotherapy or chemotherapy-naïve patients;
- •having no bone disease such as osteoporosis or osteopetrosis;
- •receiving no bisphosphonate therapy;
- •having functional prosthetic loading on the implant for at least six months
- •requiring no advanced surgical technique for the treatment of peri-implantitis.
排除标准
- •having systemic diseases such as diabetes, autoimmune disorder, renal or hepatic impairment;
- •having uncontrolled periodontal disease in natural teeth existing in the mouth;
- •smoking habit;
- •having parafunctional habits which affect osseointegration of the dental implant;
- •receiving antibiotherapy three months before the diagnosis of peri-implantitis;
- •having non-osseointegrated dental implant;
- •pregnancy and lactation.
结局指标
主要结局
Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)
时间窗: 6 months
All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure RANKL levels in the PICF samples in accordance with the manufacturer's instructions.
Osteoprotegerin (OPG) level (ng/mL)
时间窗: 6 months
All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure OPG levels in the PICF samples in accordance with the manufacturer's instructions.
Probing depth (mm)
时间窗: 6 months
Probing depth (PD) (distance from peri-implant margin to peri-implant pocket base) was measured with a plastic probe in 4 regions (mesial, buccal, distal, lingual / palatial) of each implant and recorded as mm.
次要结局
- Plaque index score (0-3)(6 months)
- Gingival index score (0-3)(6 months)
- Bleeding on probing (percentage)(6 months)
研究者
Nazli Zeynep Alpaslan
DDS, PhD, Assoc. Prof. Dr
Yuzuncu Yıl University