CTRI/2025/09/094173尚未招募不适用
Effectiveness of prior local doxycycline application in periodontal sites to be treated with Guided Tissue Regeneration – a parallel arm randomized controlled double blinded trial
Dr Athul krishna P1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年10月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Clinical attachment level gain at six months post surgery
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of prior local doxycycline application in periodontal sites treated with guided tissue regeneration (GTR) for management of furcation defects. The study hypothesis is that adjunctive use of local doxycycline before GTR will result in improved clinical attachment level gain, probing pocket depth reduction, and radiographic bone fill compared to GTR alone. A total of 68 participants will be enrolled and followed up for six months to assess clinical, radiographic, and microbiological outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 25 years and 60 years.
- •Both male and female patients.
- •Patients diagnosed with Stage III or Stage IV periodontitis with two-walled or three-walled infrabony defects, or mandibular molar Class II furcation defects.
- •Full mouth plaque score and full mouth bleeding score less than 15 percent at the time of enrollment.
- •At least one tooth with probing pocket depth more than or equal to 6 millimeters with the above mentioned defects.
- •Patients willing to undergo surgical intervention and attend follow up visits.
排除标准
- •Patients with known allergy to doxycycline or other drugs in the same class.
- •Smokers who consume more than ten cigarettes per day.
- •Patients with uncontrolled diabetes that may affect periodontal healing.
- •Pregnant or lactating women.
- •Patients with a history of periodontal surgery in the last twelve months at the same site.
- •Patients with poor plaque control despite oral hygiene instructions.
结局指标
主要结局
Clinical attachment level gain at six months post surgery
时间窗: 6 months
次要结局
- Change in probing pocket depth(Baseline and 6 months post surgery)
- Change in gingival recession(Baseline and 6 months post surgery)
- Change in bleeding on probing score
- Radiographic bone fill
- Change in defect angle
- Early wound healing index
- Post operative discomfort assessed by visual analogue scale
- Change in Porphyromonas gingivalis load assessed by real time PCR
研究者
Dr Athul Krishna P
GOVERNMENT DENTAL COLLEGE KOTTAYAM
研究点 (1)
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