| CTRI Number |
CTRI/2017/02/007898 [Registered on: 17/02/2017] Trial Registered Prospectively |
| Last Modified On: |
02/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO check the efficacy of guava leaf extract containing mouthwash in treating the gum disease. |
|
Scientific Title of Study
|
Evaluation of mouthrinse containing guava leaf extract as a part of comprehensive oral care regimen - A randomized placebo controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namratha Nayak |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College Of Dental Sciences,Manipal |
| Address |
Department of Periodontology
Room no 3
Manipal College Of Dental Sciences,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9620167824 |
| Fax |
|
| Email |
namrata.nayak2328@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jothi MV |
| Designation |
Associate Professor |
| Affiliation |
Manipal College Of Dental Sciences,Manipal |
| Address |
Room number 3
Department of Periodontology
Manipal College Of Dental Sciences,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845208532 |
| Fax |
|
| Email |
jothimv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha Nayak |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College Of Dental Sciences,Manipal |
| Address |
Room number 3
Department of Periodontology
Manipal College Of Dental Sciences,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9620167824 |
| Fax |
|
| Email |
namrata.nayak2328@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded.
Dr Namratha Nayak
Department of Periodontology
MCODS,Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Namratha Nayak |
| Address |
room no 3
Department Of Periodontology
Manipal College Of Dental Sciences. Manipal |
| Type of Sponsor |
Other [ self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal University |
Manipal University,Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namratha Nayak |
Manipal College Of Dental Sciences |
Department of Periodontology
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA |
9620167824
namrata.nayak2328@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba hospital ,Manipal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
moderate to severe gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
commercially available 0.2 % chlorhexidine mouthrine will be used. The patient will undergo thorough oral prophylaxis afetr which they will be given the chlorhexidine mouthwash to be used for a duration of 1 month after which they will be recalled for follow-up till 3 months at an interval of 1,2 and 3 months. |
| Intervention |
guava leaf extract based mouthrinse |
guava leaf will be dried and then the extract will be taken and the mouthwash will be formulated.Patient will be prescribed the mouthwash after the thorough oral prophylaxis for a period of 1 month duration after which the patient will be recalled for follow-up till 3 months at an interval of 1,2 and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Presense of a minimum of 20 functional teeth.
2. Patients with chronic generalized marginal gingivitis.
3. Patients within the age group of 18-50 years.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with removable or fixed orthodontic appliances or prosthesis.
2. Subjects who have been prescribed antibiotics or anti-inflammatory drugs in the prior 3 months that might interfere with the plaque formation.
3. Subjects who have undergone periodontal treatment in the previous 6 months
4. Subjects who consume a high polyphenol diet (including green tea or soya diet) or known allergic.
5. Subjects who have a tobacco related habit
6. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The anti microbial and anti oxidant effect of guava leaf extract based mouth rinse will be evaluated by assessing saliva and plaque samples and improvement in the clinical parameters. |
recall intervals of 1 ,2 and 3rd month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index
Plaque index |
1 2 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2017 |
| Date of Study Completion (India) |
29/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
. study hypothesis- To test the efficacy of a herbal based(guava leaf extract) mouthrinse to standard oral hygiene regimen for maintenance of oral health of patients with moderate to severe gingivitis A total of 50 systemically healthy patients diagnosed with the chronic generalized gum infection will be included. The patient will be examined at first visit and will have to visit the same dentist after one, the second and third month from the commencement of the study. At each visit, the patient will undergo a complete oral examination. Also saliva and plaque samples will be collected for the biochemical and microbiological analysis. The participants will be asked regarding any side effects observed with the use of the mouth rinses during the follow-up visits. In this study, all the patients will receive thorough oral prophylaxis after which they will be randomly allotted to the 3 groups, which are the test group (guava leaf extract mouthwash), placebo group (distilled water) and the control group ( 0.2% chlorhexidine rinses). |