| CTRI Number |
CTRI/2025/12/098554 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Other (Specify) [herbal product] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can white turmeric gel be used to clean dentures effectively |
|
Scientific Title of Study
|
Antimicrobial activity of Curcuma zedoaria Rosc white turmeric extract as denture cleansing agent An in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidisha |
| Designation |
PG student |
| Affiliation |
JSS Dental College and Hoospital, JSS Academy of Higher Education |
| Address |
Derpartment number 10,Department of Prosthodontics and Crown & Bridge, JSS Dental College and Hospital, JSS AHER, Sri Shivrathreeswara Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8551855818 |
| Fax |
|
| Email |
vidishamehta@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhakshaini MR |
| Designation |
Professor, Principal and Guide |
| Affiliation |
JSS Dental College and Hoospital, JSS Academy of Higher Education |
| Address |
Department number 10, Department of Prosthodontics and Crown & Bridge, JSS Dental College and Hospital, JSS AHER, Sri Shivrathreeswara Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8551855818 |
| Fax |
|
| Email |
dr.mrdhakshaini@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vidisha |
| Designation |
PG student |
| Affiliation |
JSS Dental College and Hoospital, JSS Academy of Higher Education |
| Address |
Department number 10, Department of Prosthodontics and Crown & Bridge, JSS Dental College and Hospital, JSS AHER, Sri Shivrathreeswara Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8551855818 |
| Fax |
|
| Email |
vidishamehta@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| Research Division, JSSAHER, JSS College, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka, India - 570015 |
|
|
Primary Sponsor
|
| Name |
JSSAHER |
| Address |
JSS Dental College and Hospital, Mysuru, Karnataka |
| Type of Sponsor |
Other [Deemed university] |
|
|
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 |
| Dr Vidisha Mehta |
JSS Dental College and Hospital |
Department number 10, Department of Prosthodontics and Crown & Bridge, JSS Dental College and Hospital, JSS AHER, Sri Shivrathreeswara Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA |
8551855818
vidishamehta@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
no systemic health conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clinsodent Denture Cleansing Tablet |
Baseline (Day 0): Swabs will be collected from the tissue surface of maxillary dentures using sterile cotton swabs, rolled on the tissue surface of the maxillary denture 3- 4 times, marked and transported in sterile test tubes for microbial analysis.
Denture Hygiene Protocol: Participants will be instructed to:
Wear dentures only during daytime.
Remove, brush, and immerse dentures overnight in water with the Clinsodent tablet, for 7 days
Follow-up (Day 7):
All the patients from each group will be recalled after one week
Swabs will be recollected from dentures using the same protocol and sent for analysis |
| Intervention |
White turmeric denture cleansing gel |
Baseline (Day 0): Swabs will be collected from the tissue surface of maxillary dentures using sterile cotton swabs, rolled on the tissue surface of the maxillary denture 3- 4 times, marked and transported in sterile test tubes for microbial analysis.
Denture Hygiene Protocol: Participants will be instructed to:
Wear dentures only during daytime.
Remove, brush, and immerse dentures overnight in water with the white turmeric denture cleansing gel applied onto the denture, for 7 days
Follow-up (Day 7):
All the patients from each group will be recalled after one week
Swabs will be recollected from dentures using the same protocol and sent for analysis |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous subjects with maxillary and mandibular heat-cured acrylic dentures (6 months – 4 years of use)
Subjects with satisfactory denture hygiene (no visible calculus on denture)
Subjects who gave informed consent |
|
| ExclusionCriteria |
| Details |
Subjects with removable partial denture
Subjects with cast partial denture.
Subjects with implant-supported denture.
Subjects with a less than 6 month of usage
Subjects with cracks or repairs or relining in their dentures.
Subjects on antibiotic, steroid or anti-fungal therapy
Subjects using mouthwashes and denture cleansers prior to study.
Subjects who did not give written informed consent.
Subjects with immunosuppressive disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| microbial analysis of swabs collected from denture to show antimicrobial activity |
baseline, 2 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vidishamehta@jssuni.edu.in].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Aim: To study the antimicrobial efficacy of C. zedoaria (whiteturmeric) extract as denture cleansing agent Hypothesis: The hypothesis of this study is that C. zedoria extract is an effective alternative to commercially available synthetic denture decontaminants Purpose: The purpose of this study is to evaluate and compare the disinfection of acrylic removable prosthesis by C. zedoria extract, with the conventional method of disinfection on contaminated prosthesis. The significance of the study is that curcumin is an economical, effective, non-toxic, acceptable and eco-friendly method of disinfection for contaminated prosthesis. |