The Effect of Hyaluronic Acid on Non-Surgical Periodontal Treatment in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 23
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the adjunctive use of hyaluronic acid (HA) improves periodontal healing in people with diabetes mellitus and periodontitis. The effects of HA on biomolecules and bacteria levels will be assessed during the follow-up period.
The main questions the study will answer are:
- Will periodontal sites treated with non-surgical periodontal treatment (NSPT) plus HA gel show better clinical periodontal parameters than sites treated with only NSPT in patients with diabetes and periodontitis?
- will HA gel have additional effect on reducing inflammation or collagen markers, and bacteria levels during follow-up?
Researchers will compare periodontal sites receiving NSPT with adjunctive HA gel application to sites receiving NSPT alone to determine whether HA provides additional clinical, biochemical and microbiological benefits.
Participants will:
- provide recent HbA1c test results.
- then, the participants will receive full-mouth NSPT then, randomization will be performed for the selected jaw for test sites. These two interproximal test sites will additionally receive HA application.
- attend follow-up visits at 1, 3 and 6 months for clinical periodontal measurements and to provide gingival crevicular fluid samples (GCF) and subgingival samples.
The GCF samples will be evaluated for interleukin-34 (IL-34) and beta C-terminal telopeptide (β-CTX) levels and subgingival samples for periodontal pathogens.
详细描述
This study is a randomized controlled split-mouth clinical trial that investigates the clinical, biochemical, and microbiological effects of adjunctive Hyadent BG® gel application into selected interproximal periodontal pocket sites after non-surgical periodontal treatment (NSPT) in patients with diabetes mellitus (DM) and stage III/IV periodontitis.
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the tooth-supporting tissues. DM is an important modifying factor for periodontal disease progression and treatment response. Hyperglycemia-related alterations in host immune response, collagen metabolism, microvascular function, and wound healing may contribute to increased periodontal inflammation and delayed periodontal healing. Therefore, adjunctive local approaches that may enhance the response to NSPT are clinically relevant in this patient population.
Hyaluronic acid (HA) is a naturally occurring glycosaminoglycan found in periodontal tissues and the extracellular matrix. Because of its hydrophilic, viscoelastic, anti-inflammatory, and wound-healing properties, HA has been investigated as an adjunctive agent in periodontal therapy. In this study, HA gel will be applied locally into periodontal pockets after scaling and root planing to evaluate whether it provides additional benefit beyond NSPT alone.
The study will include a total of 23 patients with DM and Stage III/IV periodontitis who applied to the Department of Periodontology, Faculty of Dentistry, Marmara University. Eligible participants will receive detailed information regarding the study procedures, and written informed consent will be obtained prior to enrollment.
TREATMENT PROCEDURES
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who sign the informed consent form
- •Participants diagnosed with diabetes mellitus (HbA1c %7-7.9)
- •Participants without any systemic disease other than DM
- •Participants diagnosed with Stage III or Stage IV periodontitis
- •Nonsmokers
- •Participants with at least 15 natural teeth present in the mouth (excluding third molars)
- •Participants in either of the jaws, in both quadrants, having two non-adjacent interproximal sites with probing depth and clinical attachment level ≥6 mm with no caries, restorations or furcation involvement
排除标准
- •Individuals who do not sign the informed consent form
- •Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis
- •Participants have received any periodontal treatment within 6 months prior to the study
- •Participants who have used antibiotics within the last 3 months
- •Participants who are pregnant or lactating