| CTRI Number |
CTRI/2024/08/072682 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study for use of Moringa Oleifera for gum diseases |
|
Scientific Title of Study
|
Comparative evaluation of locally delivered moringa oleifera gel and chlorhexidine gel as an adjunct to scaling and root planing in generalized periodontitis patients - A randomised cotrolled 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 |
Dr Harshda Mahajan |
| Designation |
Postgraduate Student |
| Affiliation |
Government dental college and hospital Mumbai |
| Address |
215, Department of Periodontology, Government dental college and hospital PD Mello, road Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8668410713 |
| Fax |
|
| Email |
mahajanharshada25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
Professor |
| Affiliation |
Government dental college and hospital Mumbai |
| Address |
215 Department of periodontology Government dental college and hospital PD mello road Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8668410713 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshda Mahajan |
| Designation |
Postgraduate Student |
| Affiliation |
Government dental college and hospital Mumbai |
| Address |
215, Department of Periodontology, Government dental college and hospital PD Mello, road Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8668410713 |
| Fax |
|
| Email |
mahajanharshada25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Hospital, Mumbai, India, 400001 |
|
|
Primary Sponsor
|
| Name |
Dr Harshda Mahajan |
| Address |
215, Department of Periodontology, Government dental college and hospital PD Mello, road Mumbai, India, 400001 |
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 |
| Dean Government dental college and hospital Mumbai |
Government dental college and hospital Mumbai |
215 Dept. of periodontology Government dental college and hospital Mumbai
Mumbai
MAHARASHTRA |
226206681
deangdch_mumbai@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: DANTAVESHTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Moringa Oleifera, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with generalized periodontitis stage I, II, III according to 2018 AAP/EFP classification of periodontal and peri-implant diseases with minimum 3 sites in separate quadrants.
2. Patients in age group of 21 to 60 years of either sex.
3. Patients with atleast 20 natural teeth.
4. patient ready to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients.
2. Patients on antibiotic or antimicrobial therapy in past 6 months.
3. smokers and smokeless tobacco users.
4. Patients who have received periodontal treatment in past 6 months.
5. Pregnant woman and lactating woman.
6. Patients allergic to any material used in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival Index, Probing pocket depth reduction |
1 Week, 1 Month, 3 Months, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Attachment loss |
1 Week, 1 Month, 3 Months, 6 Months |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| 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
|
Patients with stage I, II, and III periodontitis with 3 sites with pocket depth >4mm each in separate quadrants will be randomly selected for each of the 3 groups. The Moringa Oleifera gel, Placebo Gel, and Chlorhexidine gel will be given according to the groups. Baseline records will be taken and scaling and root planing will be performed. Upon completion of scaling and root planing patients will be given the above-mentioned interventions according to their groups, and then patients will be assessed at 1 week, 1 month, 3 months, 6 month intervals and measurements will be recorded for plaque index, gingival index, probing pocket depth, clinical attachment loss and then results will be drawn and published. |