| CTRI Number |
CTRI/2024/11/076971 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two mouthwash, Moringa Oleifera and Chlorhexidine Gluconate in patients with gingivitis. |
|
Scientific Title of Study
|
A comparative evaluation of 5 percent Moringa Oleifera mouthwash and 0.2 percent Chlorhexidine Gluconate mouthwash. A randomized control 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 Kanika Singhal |
| Designation |
Postgraduate student |
| Affiliation |
RUHS COLLEGE OF DENTAL SCIENCES, JAIPUR |
| Address |
Room no. 6, department of Periodontics, Government Dental College, RUHS-CDS, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
09821809949 |
| Fax |
|
| Email |
kanikasinghal317@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmistha Vijay |
| Designation |
Senior Professor |
| Affiliation |
RUHS COLLEGE OF DENTAL SCIENCES, JAIPUR |
| Address |
Room no.6, Department of Periodontics, Government Dental College, RUHS-CDS, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
09821809949 |
| Fax |
|
| Email |
sharmisthavijay@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika Singhal |
| Designation |
Postgraduate student |
| Affiliation |
RUHS COLLEGE OF DENTAL SCIENCES, JAIPUR |
| Address |
Room no.6, Department of Periodontics, Government Dental College, RUHS-CDS, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
09821809949 |
| Fax |
|
| Email |
kanikasinghal317@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics, RUHS-CDS, Jaipur, 302016 |
|
|
Primary Sponsor
|
| Name |
Dr Kanika Singhal |
| Address |
Room no.6, Department of Periodontics, Government Dental College, RUHS-CDS, Jaipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Kanika |
Government Dental College, Jaipur |
Room no.6, Department of Periodontics, Government Dental College, RUHS-CDS, Jaipur 302016
Jaipur
RAJASTHAN |
9821809949
kanikasinghal317@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee RUHS CDS Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gluconate |
1 group will be given Chlorhexidine mouthwash for 5 days before washout period and 1 group will be given after washout period. |
| Intervention |
Moringa Oleifera |
Moringa oleifera plant extract will be made into mouthwash. Mouthwash will be given for 5 days as intervention for 1 group before washout period and 1 group after washout period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy, minimum 20 functional teeth, GI score less than or equal to 2 |
|
| ExclusionCriteria |
| Details |
Malaliggned teeth, removabe or fixed partial denture, orthodontic appliance, tobacco chewer, smoker. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index- Silness and Loe |
6th and 24th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Index- Loe and Silness |
6th and 24th day |
| Bleeding Index- Muhlemann |
6th and 24th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="0"
Months="1"
Days="10" |
|
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
|
The current gold standard in mouthwashes is Chlorhexidine Gluconate, but it still has some disadvantages like staining teeth and taste alterations. So, the study here aims at finding an alternative to Chlorhexidine mouthwash which can work in a similar manner. Also, the study uses a plant extract, i.e., Moringa oleifera leaf powder, which is already available commercially for various uses. The mouthwash will be prepared in the lab and then used. |