| CTRI Number |
CTRI/2024/06/068802 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessment of Three Different Mouthwashes on Gingivitis and Dental Plaque |
|
Scientific Title of Study
|
Effect of Plantago Major, Curcuma Longa and Chlorhexidine Mouthwash on Gingivitis and Dental Plaque in Adults of Bareilly: A Randomized Cross-Over Clinical 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 Anjali Gupta |
| Designation |
Post Graduate Student First Year |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Department of Public Health Dentistry Institute of Dental Sciences Bareilly International University Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9304011482 |
| Fax |
|
| Email |
anjaliguptalovmom26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivlingesh Kamate |
| Designation |
Head of Department |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Department of Public Health Dentistry Institute of Dental Sciences Bareilly International University Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9560277157 |
| Fax |
|
| Email |
shivgesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivlingesh Kamate |
| Designation |
Head of Department |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Department of Public Health Dentistry Institute of Dental Sciences Bareilly International University Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9560277157 |
| Fax |
|
| Email |
shivgesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences, BIU, Bareilly |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Gupta |
| Address |
210 Department of public health Dentistry Institute of Dental Sciences Pilbhit Bypass Road Bareilly |
| Type of Sponsor |
Other [Bareilly International 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 Anjali Gupta |
Department of Public Health Dentistry |
Institute of Dental Sciences Bareilly International University Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH |
9304011482
anjaliguptalovmom26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IDS, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Generalized Gingivitis |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 Plantago Major Mouthwash
2 Curcuma longa Mouthwash |
All the three groups will receive all the three types of mouthwashes at different time intervals in the study
A modified case history proforma will be filled
Oral prophylaxis will be performed for all the participants 15 days prior to the study Plantago major mouthwash will be a freshly prepared homeopathic mouthwash and the participant will mix
Plantago major with distilled water daily in the ratio of 25 ml of distilled water mixed with 5ml of Plantago major
Curcuma longa mouthwash is commercially available
Chlorhexidine mouthwash is commercially available
The patient hygiene performance index and Simplified Oral hygiene index will be filled
The Gingival index will be recorded at baseline The designated mouthwash will be given to the participants The participants will continue their normal tooth brushing After 30 min the participants will be directed to rinse with 5 ml designated mouthwash for 1 minute daily
Patients will be instructed not to use water to rinse it again The Investigator will provide measuring cups with 5ml marking in order to use the correct volume of mouthwash
Participants will be advised to brush their teeth with a soft bristle toothbrush and a non-therapeutic low abrasive dentifrices
To check for compliance the subjects will be instructed to maintain a diary and record the usage of mouthwash
During the subsequent recalls subjective and objective symptoms will be noted including taste acceptance burning sensation dryness or discomfort of mouth staining of teeth ulcer formation and allergies
Relevant indices will be recorded and subjects will be instructed to follow the routine plaque control methods |
| Comparator Agent |
Chlorhexidine Mouthwash |
The comparator Agent will be given to twenty participants of group A for 2 weeks followed by wash off period of 15 days after which twenty participants of Group B will be given the mouthwash for the next 2 weeks and after 15 days of wash off period twenty participants of Group C will be given the mouthwash from 9th to 10th week as per devised methodology |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to give their consent.
Subjects within the age range of 18-25 years.
Patients suffering from Gingivitis
|
|
| ExclusionCriteria |
| Details |
•Patients who have undergone any surgical procedure in the last six months.
•Pregnant or nursing females.
•Alcohol intoxication.
•Antibiotics use in the six months before the study.
• Patients undergoing orthodontic treatment.
• Patients with systemic diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of Plantago Major, Curcuma Longa and Chlorhexidine mouthwash on gingivitis and dental plaque in adults |
Baseline- Mouthwash allocation and Baseline indices will be recorded
2nd Week- Relevant indices will be recorded
4th Week- Reallocation of mouthwash and baseline indices will be recorded
6th Week- Relevant indices recorded
8th Week- Reallocation of mouthwash and baseline indices will be recorded
10th week- Relevant indices recorded |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved gingival health & reduced dental plaque in participants |
Regular follow ups after every 3 months to assess the effect of mouthwashes |
|
|
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)
|
20/06/2024 |
| 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 - NO
|
|
Brief Summary
|
There is scarcity of
literature showing efficacy of newer natural products, hence this study will be
conducted for evaluation of Plantago major, Curcuma longa and Chlorhexidine
mouthwash (Gold Standard) on Gingivitis and Dental plaque |