| CTRI Number |
CTRI/2025/07/090392 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EXPLORING THE HEALING POTENTIAL OF DRUMSTICK LEAVES POWDER IN POSTOPERATIVE ORAL WOUNDS |
|
Scientific Title of Study
|
HEALING EFFICACY OF MORINGA OLEIFERA LEAVES POWDER IN INTRAORAL WOUND HEALING : A COMPARATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nehil Saran |
| Designation |
Senior Resident |
| Affiliation |
King George Medical College |
| Address |
Department of Periodontology, Faculty of Dental Sciences,King George Medical College, Sahamina Road,Lucknow,Uttar Pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9260927326 |
| Fax |
|
| Email |
nehilsaran85@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nehil Saran |
| Designation |
Senior Resident |
| Affiliation |
King George Medical College |
| Address |
Department of Periodontology, Faculty of Dental Sciences,King George Medical College, Sahamina Road,Lucknow,Uttar Pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9260927326 |
| Fax |
|
| Email |
nehilsaran85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nehil Saran |
| Designation |
Senior Resident |
| Affiliation |
King George Medical College |
| Address |
Department of Periodontology, Faculty of Dental Sciences,King George Medical College, Sahamina Road,Lucknow,Uttar Pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9260927326 |
| Fax |
|
| Email |
nehilsaran85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Periodontology , Faculty of Dental Sciences , King George Medical College,Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Nehil Saran |
| Address |
Department of Periodontology,
Faculty of Dental Sciences,King George Medical College,Lucknow U.P |
| 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 Nehil Saran |
Department of Periodontology |
5th Floor, Room No. 14, Department of Periodontology, New Dental Building, Faculty of Dental Sciences,King George Medical College, Sahamina Road,Lucknow,Uttar Pradesh Lucknow UTTAR PRADESH |
9260927326
nehilsaran85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University Insitutional Ethics Committee Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Intraoral postoperative |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: Periodontal Dressing mixed with moringa leaves powder & applied to intraoral wounds)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Periodontal dressing | Non eugenol periodontal dressing |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having pocket depth 04 millimetre or more than 04 millimeters, more than 20 teeth present in the oral cavity, with 30 percent of teeth having Periodontitis. |
|
| ExclusionCriteria |
| Details |
Participants with a history of any systemic disease,Pregnant and lactating females,Participants with a history of smoking,Participants who have undergone any periodontal treatment in the past 06 months prior to enrollment,History of antibiotic or antiinflammatory or mouthwash use in past 06 months prior to enrollment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing effect of Moringa oleifera leaves powder on intraoral wounds. |
at 01 week and 01 month followup respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participants satisfaction level regarding wound healing and postoperative discomfort assessed by Likert scale 1932 |
At 01 month follow up |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2025 |
| 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="0" 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 - NO
|
|
Brief Summary
|
This split-mouth clinical study aims to evaluate the woundhealing effects of Moringa oleifera also known as drumstick leaf powder, in postoperative wounds. The minimum sample size is 60 sites, and they are randomly assigned using computer software into two groups. One group will serve as the control site, and the other as the test site. One site will receive only periodontal dressing, while the other site will receive periodontal dressing combined with Moringa oleifera leaf powder.
Participants will be selected based on specific inclusion criteria, which are pocket depth equal to or greater than four millimeters, age above eighteen years, presence of more than twenty teeth, and at least thirty percent of the teeth affected by periodontitis. The exclusion criteria include a history of any systemic disease, pregnancy or lactation, smoking, having undergone periodontal treatment within the past six months, and the use of antibiotics, anti-inflammatory drugs, or mouthwash in the last six months.
Soft tissue healing will be assessed at one week and one month after the procedure using the Early Healing Index developed by Wachtel 2003 and the Healing Index by Landry in 1988. Patient satisfaction regarding wound healing and postoperative discomfort will be evaluated using a 5point Likert scale. Ethical approval will be obtained before the start of the study |