Evaluation of the Effects of Hyaluronic Acid and Albumin-PRF as Adjuncts to Non-Surgical Periodontal Treatment on Clinical and Biochemical Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Gingival Crevicular Fluid VEGF Levels
研究概览
简要总结
Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting tissues of the teeth. Non-surgical periodontal treatment is the first-line approach for the management of periodontitis; however, the use of adjunctive therapeutic agents may improve clinical outcomes.
The aim of this randomized clinical trial is to evaluate the effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) used as adjuncts to non-surgical periodontal treatment on clinical and biochemical parameters in patients with Stage III periodontitis. Participants will be randomly allocated into three groups: an Alb-PRF group, a hyaluronic acid gel group, and a control group receiving non-surgical periodontal treatment alone. Clinical periodontal parameters and biochemical markers obtained from gingival crevicular fluid will be assessed at baseline and at 1 and 3 months after treatment. The findings of this study are expected to contribute to the evaluation of the potential benefits of adjunctive biological and anti-inflammatory applications in the non-surgical periodontal treatment of patients with Stage III periodontitis.v
详细描述
This study is designed as a randomized, parallel-group clinical trial conducted in patients diagnosed with Stage III periodontitis. The aim of the study is to evaluate the adjunctive effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) when used in addition to non-surgical periodontal treatment.
A total of 51 systemically healthy volunteers will be included in the study. Participants will be randomly allocated into three groups (17 patient per group). At the initial visit, all participants will undergo clinical periodontal examination, intraoral photography, and gingival crevicular fluid sampling. Supragingival scaling will be performed for all patients at baseline. One week later, full-mouth scaling and root planing will be completed in a single session.
In the Alb-PRF group, albumin platelet-rich fibrin will be applied as an adjunctive therapy. In the hyaluronic acid group, hyaluronic acid gel will be applied following scaling and root planing and the application will be repeated at the second week. The control group will receive non-surgical periodontal treatment alone without any adjunctive application. Adjunctive treatments will be applied subgingivally immediately after periodontal therapy and one week later.
To evaluate clinical and biochemical outcomes, clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and at 1 and 3 months after treatment. Gingival crevicular fluid samples will be obtained using sterile paper strips as a non-invasive method. All collected data will be evaluated at the end of the study. The results of this study are expected to provide additional evidence regarding the effectiveness of adjunctive biological and anti-inflammatory approaches in the non-surgical treatment of Stage III periodontitis.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy individuals aged between 30 and 60 years
- •No history of periodontal treatment or antibiotic use within the last 6 months
- •Non-smokers
- •Accepting to regularly attend the follow-up sessions planned during the study period
- •Diagnosis of Stage III periodontitis
- •Presence of at least 15 teeth in the oral cavity, with more than 30% of the existing teeth affected by periodontal disease
- •Presence of probing pocket depth ≥6 mm and clinical attachment loss ≥5 mm in affected teeth
- •Presence of vertical bone loss ≥3 mm
- •Radiographic evidence of alveolar bone loss extending to the middle third or beyond (≥33%) of the root length in affected teeth
排除标准
- •Presence of any systemic disease
- •History of periodontal treatment or antibiotic use within the last 6 months
- •Pregnancy or lactation
- •Presence of acute oral lesions or necrotizing ulcerative periodontitis
- •Use of medications known to affect periodontal tissues
- •Current smoking
- •Presence of immune system disorders or use of immunosuppressive medications
- •Presence of prosthetic restorations on teeth selected for gingival crevicular fluid sampling
研究组 & 干预措施
Alb-PRF
Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF).
干预措施: Non-Surgical Periodontal Treatment (Procedure)
Alb-PRF
Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF).
干预措施: Albumin Platelet-Rich Fibrin (Alb-PRF) (Other)
Hyaluronic Acid
Participants receive non-surgical periodontal treatment with adjunctive hyaluronic acid gel application.
干预措施: Non-Surgical Periodontal Treatment (Procedure)
Control Group
Participants receive non-surgical periodontal treatment alone without any adjunctive application.
干预措施: Non-Surgical Periodontal Treatment (Procedure)
Hyaluronic Acid
Participants receive non-surgical periodontal treatment with adjunctive hyaluronic acid gel application.
干预措施: Hyaluronic Acid Gel (Other)
结局指标
主要结局
Change in Gingival Crevicular Fluid VEGF Levels
时间窗: Baseline, 1. month and 3. months
Changes in vascular endothelial growth factor (VEGF) levels in gingival crevicular fluid will be analyzed to evaluate angiogenic activity.
Change in Gingival Crevicular Fluid IL-1 Beta Levels
时间窗: Baseline, 1. month and 3. months
Changes in interleukin-1 beta (IL-1β) levels in gingival crevicular fluid will be assessed as a marker of inflammation.
Change in Gingival Crevicular Fluid IL-10 Levels
时间窗: Baseline, 1. month and 3. months
Changes in interleukin-10 (IL-10) levels in gingival crevicular fluid will be evaluated to assess anti-inflammatory response.
次要结局
- Change in Probing Pocket Depth(Baseline, 1. month and 3. months)
- Change in Plaque Index(Baseline, 1. month and 3. months)
- Change in Gingival Index(Baseline, 1. month and 3. months)
- Change in Bleeding on Probing(Baseline, 1 month and 3 months)
- Change in Clinical Attachment Level(Baseline, 1. month and 3. months)
研究者
Furkan Kuşoğlu
Research Assistant
Inonu University