| CTRI Number |
CTRI/2024/12/078498 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing and evaluating the effect of 0.2 percent chlorhexidine mouthwash and herbal mouthwash on salivary bacterial load |
|
Scientific Title of Study
|
Comparative evaluation of the Antimicrobial efficacy of 0.2 percent Chlorhexidine and Herbal mouthwash on Salivary Bacterial load: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh R Khairnar |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences IMS, Banaras Hindu University, Varanasi ,221005, Uttar Pradesh, India |
| Address |
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi,221005, Uttar Pradesh India.
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi,221005, Uttar Pradesh India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7045653288 |
| Fax |
|
| Email |
kmahesh222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ridhi Ghodela |
| Designation |
Post Graduate Student 2nd year |
| Affiliation |
Faculty of Dental Sciences IMS, Banaras Hindu University, Varanasi ,221005, Uttar Pradesh, India |
| Address |
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9129535021 |
| Fax |
|
| Email |
ridhighodela20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh R Khairnar |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences IMS, Banaras Hindu University, Varanasi ,221005, Uttar Pradesh, India |
| Address |
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7045653288 |
| Fax |
|
| Email |
kmahesh222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi,221005, Uttar Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Dr Mahesh R Khairnar |
| Address |
Fourth Floor room no.8 Public Health Dentistry, Faculty of Dental Science, IMS, Banaras Hindu University,221005, Varanasi, Uttar Pradesh. |
| Type of Sponsor |
Other [Self sponsored by the primary investigator] |
|
|
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 Mahesh R Khairnar |
Banaras Hindu University |
Fourth floor room no.8 Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH |
7045653288
kmahesh222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University -Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, (2) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash I.P. Hexidine antiseptic -antiplaque |
Pharmaceuticals available in 80ml (0.2%w/v) bottle containing chlorhexidine gluconate solution I.P. diluted to chlorhexidine gluconate 0.2% w/v in pleasantly flavoured aqueous base having brilliant blue color administered 5ml of mouthwash twice daily as a comparator group for period of 10 days. |
| Intervention |
Oralife oral rinse and throat gargle with natural extracts |
Pharmaceuticals available in 100ml bottle containing 0.6% grapefruit seed extracts jambir, 0.2% pomegranate dadima, 0.07% thymol yavanisatva,7.0% xylitol,0.16% citric acid anhydrous administered 5ml of mouthwash twice daily for intervention period of 10 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients having mild to moderate gingivitis reporting in OPD of Faculty of Dental Sciences IMS BHU.
All teeth and surrounding tissues were clinically and radiographically free of any other pathologic condition.
Healthy individuals without any systemic diseases.
|
|
| ExclusionCriteria |
| Details |
Physical limitations, which might preclude the normal tooth brushing and mouth rinsing.
Presence of any severe intraoral infections.
Medically compromised patients or those who were on any long-term medication.
Subjects with history of taking antibiotics 1 month prior to or during the course of study.
Patient reporting with pain or history of pain requiring immediate treatment.
Subjects with fixed or removable orthodontic appliances or removable prosthesis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of salivary bacterial load and candida albicans |
Assessment of salivary bacterial load and candida albicans at baseline ,immediate after rinsing with mouthwash and after 10 days of regular rinsing with mouthwash |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
This Randomized Controlled Trial will be conducted for a period of ten days on 20 randomly selected patients having mild to moderate gingivitis allocated into two groups - 0.2% chlorhexidine mouthwash and oralife mouthwash, ten in each group. Unstimulated saliva samples will be collected before rinsing with mouthwash, immediately after rinsing with mouthwash and one hour after using mouthwash and on eleventh day after usage of mouthwash 5ml twice daily for ten days. Sample will be examined in laboratory for microbiological assessment to measure the bacterial load and candida albicans. |