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CTRI Number  CTRI/2024/08/072097 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study Comparing Moringa Oleifera Mouthwash With Chlorhexidine And Salt water Concentration To Check Anti Plaque and Anti Gingivitis Effect in Gingivitis Patients 
Scientific Title of Study   Comparing The Anti-Plaque And Anti-Gingivitis Efficacy Of Moringa Oleifera Mouthwash To Chlorhexidine And Saltwater Concentration In Treating Gingivitis: A Randomized Controlled 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 Snigdha Kandukuri 
Designation  Post-Graduate Student 
Affiliation  AMEs Dental College And Hospital 
Address  Room No-6,Department of Periodontics and Oral Implantology, AMEs Dental College and Hospital, Raichur, Karnataka

Raichur
KARNATAKA
584103
India 
Phone  7396163715  
Fax    
Email  snigdhakandukuri96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nagappa Guttiganur 
Designation  Guide 
Affiliation  AMEs Dental College And Hospital 
Address  Room No-6,Department of Periodontics and Oral Implantology, AMEs Dental College and Hospital, Raichur, Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9986315772  
Fax    
Email  nagunags@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Snigdha Kandukuri 
Designation  Post-Graduate Student 
Affiliation  AMEs Dental College And Hospital 
Address  Room No-6,Department of Periodontics and Oral Implantology, AMEs Dental College and Hospital, Raichur, Karnataka

Raichur
KARNATAKA
584103
India 
Phone  7396163715  
Fax    
Email  snigdhakandukuri96@gmail.com  
 
Source of Monetary or Material Support  
Room No-6, Department of periodontics and Oral implantology, AMEs Dental college and hospital, Raichur, Karnataka,India-584103 
 
Primary Sponsor  
Name  Dr Snigdha Kandukuri 
Address  Room.No-6,Dept Of Periodontics and Oral Implantology, AMEs Dental College and Hospital, Raichur, Karnataka,India-584103 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSnigdha Kandukuri  AMEs Dental College and Hospital  Room no-6,Department of Periodontics and Oral Implantology,AMEs Dental College and Hospital,Raichur,Karnataka,584103
Raichur
KARNATAKA 		 7396163715

snigdhakandukuri96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee IECAMEDCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Salt water concentrationRoute-oral,Dose-10ml twice daily for 2 weeks
2Comparator Arm (Non Ayurveda)-Chlorhexidine mouthwashRoute-oral,Dose-10ml twice daily for 2 weeks
3Intervention ArmDrugOther than Classical(1) Medicine Name: Moringa Oleifera, Reference: NA, Route: Oral, Dosage Form: Arishta, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  After taking a detailed medical history and initial clinical Examination,
1.Systemically healthy individuals with previously untreated gingivitis
2.The individuals with ≥ 20 teeth were selected.
Clinical parameters for inclusion are :
3.OHI-S Index ( Greene and Vermillion 1964) – 0.1 - 3.0 Score
4.Plaque Index ( Turesky et al Modification of the Quigley Hein (TQHPI) 1962) – ≤ 4 Score
5.Gingival Index (Loe and silness 1963) – 0.1-2.0 Score
6.Probing depth - ≤ 3mm
 
 
ExclusionCriteria 
Details  1)Use of Antibiotics & Anti-inflammatory drugs in the previous 6 months.
2)Individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation
3)Allergy to any ingredients used in the study.
4)Alcoholism.
5)Smokers or users of tobacco in any form.
6)pregnancy and Lactating females.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. anti plaque effect
2. anti gingivitis effect 		 After 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
questionnaire regarding burning, discoloration,dryness,
alteration in taste 		 after 2 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   01/09/2024 
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="0"
Days="14" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [snigdhakandukuri96@gmail.com].

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 01-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The study will be a double-blinded, parallel-designed randomized controlled trial will be conducted in the Department of Periodontics and Oral Implantology at A.M.E’s Dental College and Hospital, Raichur, Karnataka. The study population will consist of undergraduates aged 18-25 years enrolled at A.M.E’s Dental College and Hospital, Raichur, Karnataka. The study will include three groups (A, B, C), each comprising 12 participants selected randomly through a simple lottery method as follows: Group A (N=12) - Moringa oleifera mouthwash, Group B (N=12) - Chlorhexidine mouthwash, and Group C (N=12) - Saline water concentration. An impartial individual will be responsible for conducting the allocation and product coding. All 36 participants will be instructed to use a soft toothbrush with toothpaste and practice a sulcular brushing technique for optimal oral care. The study will adhere to a double-blind design, ensuring that both examiners and participants remain unaware of the mouth rinses assigned. Participants will use 10 ml of mouthwash for 1 minute, twice daily after brushing their teeth for 2 weeks, with the quantity measured using 10 ml cups. Anti-plaque and Anti-Gingivitis Efficacy of mouthwashes will be assessed using the OHI-S index (Greene and Vermillion, 1964), the Gingival index (Loe and Silness, 1963), and the Turesky-Gilmore-Glickman 1970 modification of the Quigley-Hein plaque index. Assessments will be conducted at the study’s baseline and after 2 weeks. For plaque inspection, a two-tone dye-disclosing agent will be applied to all tooth surfaces. Gingivitis severity will be evaluated across four scoring units: disto-facial papilla, facial margin, mesial facial papilla, and the entire lingual gingival margin. Additionally, participants will complete a questionnaire regarding any discomfort (burning, itching, dryness, taste disturbance) and tooth discoloration.

 
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