| CTRI Number |
CTRI/2025/06/089250 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of Chlorhexidine Mouthwash and Liquorice Extract Mouthrinse, on oral hygiene in Orthodontic Patients: A Comparative Study |
|
Scientific Title of Study
|
Effect of 0.12 percent Chlorhexidine Mouthwash and 2.5 percent Liquorice Extract Mouthrinse, on periodontal parameters in Orthodontic Patients: A Comparative 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 |
Varsha Dogra |
| Designation |
Post Graduate Student |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Department of Orthodontics and dentofacial Orthopedics, Room no. 11, Government College of Dentistry, 1, Sardar Patel Marg, Opposite M.Y. Hospital
25, Rajendra Niketan, Super corridor Road, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9977245769 |
| Fax |
|
| Email |
varshadogra62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ram Kishore Ratre |
| Designation |
Head of Department, Professor |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, Government College of Dentistry, 1, Sardar Patel Marg, Opposite M.Y. Hospital
Indore
MADHYA PRADESH
452001
India |
| Phone |
9425070696 |
| Fax |
|
| Email |
rkratre@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Dogra |
| Designation |
Post Graduate Student |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, Room - 11, Government College of Dentistry, 1, Sardar Patel Marg, Opposite M.Y. Hospital
25, Rajendra Niketan, Super corridor Road, Indore
MADHYA PRADESH
452001
India |
| Phone |
9977245769 |
| Fax |
|
| Email |
varshadogra62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government College of Dentistry |
|
|
Primary Sponsor
|
| Name |
Varsha Dogra |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, Room 11, Government College Of Dentistry, Indore, Madhya Pradesh, India, Pin- 452001 |
| Type of Sponsor |
Other [Individual sponsor] |
|
|
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 |
| Varsha Dogra |
Government College of Dentistry, Indore |
Department of Orthodontics & Dentofacial Orthopedics, Room no- 11, Government College of Dentistry, 1, Sardar Patel Marg, Opposite M.Y. Hospital
Indore
MADHYA PRADESH |
09977245769
varshadogra62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Govt. College of Dentistry, Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fixed Orthodontic Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.12% Chlorhexidine Mouthwash |
Gold Standard Mouthwash
Dose - 10 ml of Mouthrinse twice a day - oral route |
| Intervention |
2.5% Liquorice Extract Mouthwash |
Herbal Mouthwash(Liquorice Root Extract)
Dose - 10 ml of Mouthrinse twice a day - oral route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients with good general health.
b. Patients undergoing orthodontic treatment.
c. Patients with no antibiotic intake or use of antibacterial mouthrinses in the previous 3 months,
d. Patients with no periodontal disease.
e. Non-smoker, Non- alcoholic.
f. No acute oral diseases, oral infections, need for immediate periodontal care.
g. Patients willing to give the consent form
|
|
| ExclusionCriteria |
| Details |
a. Any known systemic disease which effects the periodontium
b. Volunteers on anti-inflammatory, antibiotics, steroids since 3 months
c. Volunteers who had dental caries
d. Volunteers known allergic to any product used in the study
e. Non-orthodontic patients
f. Patients with recent extraction
g. Acute oral infection
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Herbal Liquorice Mouthwash is better and cheap alternative to Chlorhexidine Mouthwash |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Less Incidence of side effects:
-Tooth staining
-Altered taste sensation
-Oral mucosal irritation
Patient acceptability & compliance:
Based on subjective feedback regarding taste, ease of use, & willingness to continue the mouthrinse long-term.
|
1 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2025 |
| 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="4"
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 - 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 - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- 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 [varshadogra62@gmail.com].
- For how long will this data be available start date provided 15-06-2025 and end date provided 05-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Orthodontic treatment with fixed appliances increases the risk of plaque accumulation and gingival inflammation due to the difficulty in maintaining oral hygiene. This randomized, crossover clinical study compared the effectiveness of 0.12% chlorhexidine (CHX) mouthwash and 2.5% liquorice extract (LE) mouthrinse in improving periodontal health among 30 orthodontic patients. Both mouthrinses significantly reduced plaque and gingival indices, with CHX showing slightly greater efficacy. However, CHX use was associated with side effects such as tooth staining and altered taste, while LE was well tolerated with minimal adverse effects. The results suggest that 2.5% liquorice mouthrinse may serve as a viable herbal alternative to CHX in orthodontic care. |