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临床试验/CTRI/2025/10/096054
CTRI/2025/10/096054尚未招募2 期

Evaluation of efficacy of 0.3% Nutmeg (Myristica fragrans) Gel as Local Drug Delivery in smokers with Stage-II Periodontitis – A Randomised clinical study

未提供1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月10日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Gracelin Solomon J

SRM UNIVERSITY

研究点 (1)

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