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CTRI Number  CTRI/2018/11/016395 [Registered on: 20/11/2018] Trial Registered Prospectively
Last Modified On: 16/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Herbal mouthwash for bleeding gums and plaque control 
Scientific Title of Study   A study validating the efficacy of a herbal mouthwash in reduction of plaque and gingivitis: An in vitro evaluation and a randomized controlled clinical trial 
Trial Acronym  HMW in GI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  O P Kharbanda  
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences  
Address  Division of Orthodontics and Dentofacial orthopedics Centre for Dental Education and Research All India Institute of Medical Sciences

South West
DELHI
110029
India 
Phone  9899062144  
Fax    
Email  opk15@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  O P Kharbanda  
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences  
Address  Division of Orthodontics and Dentofacial orthopedics Centre for Dental Education and Research All India Institute of Medical Sciences

South West
DELHI
110029
India 
Phone  9899062144  
Fax    
Email  opk15@hotmail.com  
 
Details of Contact Person
Public Query  
Name  O P Kharbanda  
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences  
Address  Division of Orthodontics and Dentofacial orthopedics Centre for Dental Education and Research All India Institute of Medical Sciences

South West
DELHI
110029
India 
Phone  9899062144  
Fax    
Email  opk15@hotmail.com  
 
Source of Monetary or Material Support  
National Innovation Foundation-India Autonomous body of Department of Science and Technology, Govt. of India Gandhinagar-382650, Gujrat, India 
 
Primary Sponsor  
Name  National innovation Foundation 
Address  National Innovation Foundation-India Autonomous Body of Department of Science and Technology, Govt. of India, Gandhinagar - 382650, Gujarat, India  
Type of Sponsor  Government funding agency 
 
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 
Dr O P Kharbanda  Centre for Dental Education and Research  Room No. 413, Division of Orthodontics, All India Institute of Medical Sciences
South West
DELHI 		 9899062144

opk15@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine mouthwash  Subjects will be given chlorhexidine mouthwash and asked to rinse for 2 min and expectorate. Subsequent to baseline estimation (set 1), each participant will undergo two sets of saliva sample collection along with estimation of salivary pH in two phases: Ten minutes after the mouthrinse (set 2), and 60 min after the mouthrinse (set 3) for salivary pH estimation. Individuals will be instructed to use 15 ml mouthwash twice daily, 30 to 45 minutes after brushing.All examinations and scorings will be done under identical working conditions at baseline and days 7, 30, and 60.  
Intervention  Herbal mouthwashes  Subjects will be given the herbal mouthwash and asked to rinse for 2 min and expectorate. Subsequent to baseline estimation (set 1), each participant will undergo two sets of saliva sample collection along with estimation of salivary pH in two phases: Ten minutes after the mouthrinse (set 2), and 60 min after the mouthrinse (set 3) for salivary pH estimation. Individuals will be instructed to use 15 ml mouthwash twice daily, 30 to 45 minutes after brushing.All examinations and scorings will be done under identical working conditions at baseline and days 7, 30, and 60. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  After taking a detailed medical history and initial clinical and radiologic examination, systemically healthy individuals of an age range of 18-40 years with previously untreated gingivitis and greater than or equal to 20 teeth with no visible signs of untreated dental caries will be selected. Clinical parameters for inclusion will be: 1) gingival index (GI) greater than 1; 2) probing depth less than equal to 3 mm; 3) clinical attachment loss should be 0, with no evidence of radiographic bone loss. Absence of bone loss will be considered when the distance between cemento-enamel junction and crestal bone is less than equal to 1 mm. 
 
ExclusionCriteria 
Details  1) Use of antibiotics and anti-inflammatory drugs in previous 6 months; 2) individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation and plaque control; 3) allergy to any ingredient used in the study; 4) alcoholics; 5) smokers or users of tobacco in any form; 6) individuals with mental retardation or medical illness; 7) Use of mouthwashes and vitamin supplements in last 3 months; 8)History of any periodontal therapy in last months; and 7) pregnant or lactating females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement of gingival and plaque indices   Baseline, 1 week, 1 month, 2 months  
 
Secondary Outcome  
Outcome  TimePoints 
Microbial count.   Baseline-7 days-30 days-60 days 
Patient acceptance (irritation of taste, subjective tooth staining)  60 days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/01/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published Publications which may arise 1. Effect of new herbal mouthwash on reduction of plaque and gingivitis: a randomized clinical trial 2. The effect of herbal mouthrinse on Streptococcus mutans count and salivary pH: An in vivo study  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

    The aim of the present study is to evaluate the efficacy of herbal mouthwashes with chlorhexidine mouthwash in patients with mild to moderate gingivitis for reduction of plaque and gingivitis scores, Microbial counts and salivary pH reduction and to assess patient acceptance (irritation of taste, subjective tooth staining). One hundred twenty individuals with chronic generalized gingivitis will be randomly assigned to three groups: 1) group I, Chlorhexidine mouthwash; 2) group II, Herbal mouthwash A; and 3) group III, Herbal mouthwash B. All individuals will be instructed to rinse with 15 ml of their respective mouthwash twice daily. 1) plaque index (PI); 2) gingival index (GI); 3) oral hygiene index-simplified (OHI-S); and 4) microbiologic colony counts will be recorded at baseline and at 7, 30, and 60 days. 

      Subsequent to baseline estimation (set 1), each participant will undergo two sets of saliva sample collection along with estimation of salivary pH in two phases: Ten minutes after the mouthrinse (set 2), and 60 min after the mouthrinse (set 3). 

 


 
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