| CTRI Number |
CTRI/2018/01/011175 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of tulsi leaf extract containing gel in treating patients with gum disease |
|
Scientific Title of Study
|
Comparative evaluation of Antimicrobial and Anti-gingivitis effect of Ocimum sanctum Linn. gel with 0.2% Chlorhexidine gel- A double blind placebo controlled randomized 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 Anupa Jankish |
| Designation |
Postgraduate |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Periodontology
room no 3
Manipal College of Dental Sciences
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9916409716 |
| Fax |
|
| Email |
anupajankish70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jothi M Varghese |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Periodontology
room no 3
Manipal College of Dental Sciences
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845208532 |
| Fax |
|
| Email |
jothimv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jothi M Varghese |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Periodontology
room no 3
Manipal College of Dental Sciences
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845208532 |
| Fax |
|
| Email |
jothimv@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded .
Dr Anupa Jankish
Department of Periodontology
MCODS, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Anupa Jankish |
| Address |
Department of Periodontology
room no 3
Manipal College of Dental Sciences
Manipal
Udupi |
| 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 Anupa Jankish |
Manipal College of Dental Sciences |
Department of Periodontology
room no 3
Manipal College of Dental Sciences
Manipal
Udupi
Udupi
KARNATAKA |
9916409716
anupajankish70@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
moderate to severe gingivitis, (1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2 % chlorhexidine gel (ELUGEL) |
commercially available 0.2% chlorhexidine gel will be used. the patient will undergo thorough oral prophylaxis after which they will be given the chlorhexidine gel to be used for a duration of 15 days after which the patient will be recalled for follow up of 15 days and 3 months interval |
| Intervention |
placebo gel |
a placebo gel will be formulated. after thorough oral prophylaxis patient will be given the gel to be used for 15 days after which the patient is recalled for follow up at 15 days and 3 months intervals |
| Intervention |
tulsi leaf extract based gel |
tulsi leaf will be shade dried and powdered. the extract will be taken from the powder and the gel will be formulated. after thorough oral prophylaxis patient will given the gel to be used for a duration of 15 days after which the patient will be recalled for follow up at 15 days and 3 months intervals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.presence of a minimum of 24 functional teeth
2.patients with moderate to severe form of gingivitis
3.patients withtin the age group of 18-45 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 past 3-6 months
3.Patients with any systemic involvement
4.Subjects with any reported allergy
5.Subjects with any tobacco related habits
6. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The antimicrobial and anti-gingivitis effect of tulsi leaf extracr based gel will be evaluated by assesssing the plaque samples and improvement in the clinical parameters |
recall intervals of 15 days and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
plaque index
gingival index
modified sulcus bleeding index |
recall intervals of 15 days and 3 months follow up |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2018 |
| Date of Study Completion (India) |
31/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
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 (tulsi leaf extract) gel in addition to standard oral hygiene practice in patients with moderate to severe gingivitis
A total of 60 systemically healthy patients diagnosed with chronic generalised gum infection will be included. Complete oral examination along with clinical parameters and plaque samples will be taken, after which all patients will undergo thorough oral prophylaxis (cleaning of teeth). After this they will be randomly allocated into any of the three groups. of which one group will receive the experimental tulsi gel (test group), second group will get chlorhexidine gel (control group) and the third group will get a placebo gel (placebo group). instructions on usage of the gel and oral hygiene instructions will be given to the patient. the patient will be recalled for follow up at 15 days and 3 months. during the initial and follow up visits complete oral examination will be done along with collection of plaque samples for clinical and microbiological analysis. |