Evaluation of efficacy of 0.3% Nutmeg (Myristica fragrans) Gel as Local Drug Delivery in smokers with Stage-II Periodontitis – A Randomised clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the therapeutic efficacy of 0.3% Nutmeg (Myristica fragrans) gel when used as a local
研究概览
简要总结
PREPARATION OF NUTMEG GEL
A 5 g of nutmeg powder will be mixed with 100 ml of distilled water
The obtained solution will be heated at 65 degrees centigrade for 15 minutes resulting in nutmeg extract
Then 2 ml of propylene glycol
4 ml of 95 percentage
ethanol 0.12 g methyl paraben
0.01 ml triethanolamine
0.05 mg piperine and
150 mg of carbopol
934 will be added to 20 ml of distilled water
and a thick mixture will be obtained
To this mixture 1 ml of nutmeg extract will be added to obtain 30 g of 0.3percentage nutmeg gel
STUDY PROCEDURE
A total of 70 stage-II periodontitis patients who are current smokers will be allocated Randomly Using
Simple Simple Randomisation
Lot Method to Group A 35 patients
and Group B 35 patients
Group A
Patients will be subjected to SRP alone
Group B
Along with SRP 1 ml of 0.3 percentage nutmeg gel will be injected into the periodontal pocket with the help of
a syringe immediately after SRP
Patients will be given instructions to avoid hard or sticky foods, and brushing or using interdental aids will
be refrained from near the treated areas for one week. Patients will be scheduled for a review after three
months
After 3 months PPD and CAL will be recorded and sent for statistical analysis
Inclusion Criteria
Smokers aged between 25-55years ASA-II
Have a probing pocket depth of 5 mm or more
Having clinical attachment loss between 3 to 4 mm
No history of periodontal therapy in the preceding 6 months
No use of antibiotics in the preceding 6 months
Exclusion Criteria
Subjects with allergies
Tobacco users in any form other than smoking
Immunocompromised individuals
PARAMETERS TO BE ANALYSED
Probing pocket depth and Clinical Attachment Level before application of 0.3 percentage nutmeg gel
and 3 months after application of 0.3 percentage nutmeg gel
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Have a probing pocket depth (PPD) of less than or equal to 5 mm Having clinical attachment loss (CAL) between 3 to 4 mm No history of periodontal therapy in the preceding 6 months No use of antibiotics in the preceding 6 months.
排除标准
- •Subjects with allergies Tobacco users in any form other than smoking Medically compromised individuals.
结局指标
主要结局
To evaluate the therapeutic efficacy of 0.3% Nutmeg (Myristica fragrans) gel when used as a local
时间窗: at 3 months after placing LDD
drug delivery (LDD) in smokers diagnosed with Stage-II periodontitis
时间窗: at 3 months after placing LDD
次要结局
- To assess the reduction in probing pocket depth (PPD) & Clinical Attachment Level (CAL)(following application of nutmeg gel.)
研究者
Gracelin Solomon J
SRM UNIVERSITY
