A Comparative Evaluation of Two Different Types of Commercially Available Topical Gels as an Adjunct to Scaling and Root Planing in Management of Gingival Inflammation - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Periodontal probing depth (PPD)
研究概览
简要总结
This randomized controlled clinical trial was undertaken to evaluate and compare the effectiveness of chlorhexidine gluconate gel (1%) alone and a combination gel containing chlorhexidine gluconate (0.5%) with metronidazole (1.5%) as adjuncts to scaling and root planing in the management of gingival inflammation over a period of 12 weeks.
120 participants were assigned to three groups: scaling and root planing with placebo gel, scaling and root planing with 1% chlorhexidine gluconate gel, and scaling and root planing with a combination of 0.5% chlorhexidine gluconate and 1.5% metronidazole gel. Clinical periodontal parameters were assessed to compare the effectiveness of the interventions in reducing plaque accumulation and gingival inflammation.
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, Investigator)
盲法说明
The intervention tubes were covered with opaque labels and coded as A, B, and C by an individual not directly involved in treatment. The tubes were dispensed according to a computer generated randomization sequence, and the principal investigator/operator was unaware of the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18- 50 years.
- •Patients with at least >20 teeth.
- •Patients with gingivitis and stage-1 grade A periodontitis.
- •Patients with clinical criteria of gingival index ≥ 1 (Loe and Silness).
- •Systematically healthy patient with no co-morbidities.
- •History of no active periodontal treatment in the last 6 months.
排除标准
- •History of smoking or use of smokeless tobacco.
- •Pregnant or lactating females.
- •Subjects with removal or fixed dental prosthesis and undergoing orthodontic treatment.
- •Use of antibiotics in the last 30 days.
- •Subjects with hematological disorders, immunocompromised and any other systemic illnesses.
- •History of chronic alcoholism.
- •Allergic to Metronidazole or Chlorhexidine.
- •Patients on medications that have effects on gingival enlargements.
研究组 & 干预措施
Placebo group (control group)
Participants received supragingival and subgingival scaling followed by topical application of placebo gel. Participants were instructed to apply a pea-sized amount of gel gently to the gingiva after brushing for approximately two minutes, twice daily for 6 weeks.
干预措施: Placebo Gel (Drug)
Test Group1- Chlorhexidine
Participants received supragingival and subgingival scaling followed by topical application of 1% chlorhexidine gluconate gel. The gel was applied twice daily for 6 weeks.
干预措施: Chlorhexidine Gluconate Gel 1% (Drug)
Test Group 2- Chlorhexidine + Metronidazole
Participants received supragingival and subgingival scaling followed by topical application of a combination of 0.5% chlorhexidine gluconate gel and 1.5% metronidazole gel. The gel was applied twice daily for 6 weeks.
干预措施: Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel (Drug)
结局指标
主要结局
Change in Periodontal probing depth (PPD)
时间窗: Baseline and 12 weeks
Periodontal probing depth was measured in millimeters using a periodontal probe to evaluate changes in periodontal pocket depth following the assigned intervention.
Change in plaque index (PI)
时间窗: Baseline and 12 Weeks
"Plaque accumulation was assessed using the Silness and Löe Plaque Index. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and therefore a worse outcome. Change was assessed from baseline to 12 weeks."
Change in gingival index (GI)
时间窗: Baseline and 12 weeks
"Gingival inflammation was assessed using the Löe and Silness Gingival Index. Scores range from 0 to 3, with higher scores indicating greater gingival inflammation and therefore a worse outcome. Change was assessed from baseline to 12 weeks."
次要结局
未报告次要终点
研究者
Dr. Abhishek Sharma
Postgraduate student, Department of Periodontology
H.P. Government Dental College and Hospital Shimla