Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Bone fill
研究概览
简要总结
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.
详细描述
Source from where the patients will be selected:
10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.
A detailed clinical examination, case history and written consent will be obtained from all the participants.
Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group between 30-50 years
- •Probing pocket depth ≥ 5mm following initial therapy.
- •Suitable interproximal angular infrabony defects of ≥3mm.
- •Involved teeth should be vital and asymptomatic.
- •Systemically healthy patients.
- •Patients who demonstrate acceptable oral hygiene prior to access flap surgery.
- •Patients agreed to sign informed consent and willing to return for the follow up visits.
排除标准
- •Systemic statin therapy
- •Known or suspected allergy to the statin group
- •Allergy to sulfur containing drugs
- •History of aggressive periodontitis.
- •Presence of gingival recession at the surgical site.
- •Mobility of study teeth ≥ grade I.
- •Use of tobacco in any form.
- •Pregnant and lactating women.
- •patients who have received any anti-inflammatory drugs and antibiotics in the previous six months.
- •H/O osteoporosis.
研究组 & 干预措施
ROSUVASTATIN
1.2% Rosuvastatin Gel. Insertion in infrabony defects once
干预措施: Rosuvastatin (Drug)
placebo
No intervention used on control site
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Bone fill
时间窗: 6 months
Radiographic parameter measuring distance from cemento-enamel junction to the base of the defect. Difference in the measurement at the end of 6 months shows the amount of bone fill
次要结局
- Probing depth(6 months)
- relative attachment level(6 months)
- plaque index(6 months)
- bleeding index(6 months)
研究者
DR. SUKHADA DEO
Principal investigator
Dr. D. Y. Patil Dental College & Hospital