| CTRI Number |
CTRI/2025/10/096054 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess if a gel made from nutmeg (Myristica fragrans) can improve gum health in smokers who have moderate gum disease (Stage II periodontitis) |
|
Scientific Title of Study
|
Evaluation of efficacy of 0.3% Nutmeg (Myristica fragrans) Gel as Local Drug Delivery in smokers with Stage-II Periodontitis – A Randomised clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gracelin Solomon J |
| Designation |
Postgraduate Student |
| Affiliation |
SRM UNIVERSITY |
| Address |
4th floor
Department of Periodontology
SRM KATTANKULATHUR DENTAL COLLEGE
4th floor
Department of Periodontology
SRM KATTANKULATHUR DENTAL COLLEGE
SRM NAGAR , POTHERI
Chennai
TAMIL NADU
603203
India |
| Phone |
07339340286 |
| Fax |
|
| Email |
gj8379@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravishankar P L |
| Designation |
Professor and Head |
| Affiliation |
SRM UNIVERSITY |
| Address |
4th floor
Department of Periodontology
SRM KATTANKULATHUR DENTAL COLLEGE
4th floor
Department of Periodontology
SRM KATTANKULATHUR DENTAL COLLEGE
SRM NAGAR , POTHERI
Chennai
TAMIL NADU
603203
India |
| Phone |
09848113248 |
| Fax |
|
| Email |
ravishak@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gracelin Solomon J |
| Designation |
Postgraduate Student |
| Affiliation |
SRM UNIVERSITY |
| Address |
4th floor
Department of Periodontology
SRM KATTANKULATHUR DENTAL COLLEGE
4th floor
Department of Periodontology
SRM KATTANKULATHUR DENTAL COLLEGE
SRM NAGAR , POTHERI
TAMIL NADU
603203
India |
| Phone |
07339340286 |
| Fax |
|
| Email |
gj8379@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Kattankulathur Dental College and Hospital , SRM University |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gracelin Solomon J |
SRM Institute of Science and Technology |
4th Floor
Department of Periodontology
SRM Kattankulathur Dental College and Hospital
SRM University
Potheri
Chennai
TAMIL NADU |
07339340286
gj8379@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.3% Nutmeg (Myristica fragrans) Gel |
Along with SRP, 1 ml of 0.3% nutmeg gel will be injected into the periodontal pocket with the help of a syringe immediately after SRP and coe pack will be placed.
|
| Comparator Agent |
Scaling And Root planing alone |
Only Scaling And Root planing will be done. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Subjects with allergies
Tobacco users in any form other than smoking
Medically compromised individuals
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the therapeutic efficacy of 0.3% Nutmeg (Myristica fragrans) gel when used as a local
drug delivery (LDD) in smokers diagnosed with Stage-II periodontitis |
at 3 months after placing LDD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the reduction in probing pocket depth (PPD) & Clinical Attachment Level (CAL)
following application of nutmeg gel. |
at 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |