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CTRI Number  CTRI/2018/02/011675 [Registered on: 05/02/2018] Trial Registered Retrospectively
Last Modified On: 30/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effect of a herbal mouthwash and chlorhexidine mouthwash on the inflammation of gums. 
Scientific Title of Study   Effectiveness of Herbal and 0.12% Chlorhexidine mouthwash on Gingivitis and Salivary Neutrophils Count. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Sharda 
Designation  Post-Graduate Student 
Affiliation  SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL 
Address  SDM College of Dental sciences and Hospital, Dept of Public Health Dentistry, Sattur.

Dharwad
KARNATAKA
580009
India 
Phone  9731278744  
Fax    
Email  shwetasharda1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Preetha J Shetty 
Designation  Professor and Head of the Department 
Affiliation  SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL 
Address  SDMCDSH. DEPT OF PUBLIC HEALTH DENTISTRY, DHARWAD

Dharwad
KARNATAKA
580009
India 
Phone  9845009979  
Fax    
Email  shetty.preetha@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Shweta Sharda 
Designation  Post Graduate Student 
Affiliation  SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL 
Address  SDMCDSH. Dept of Public Health Dentistry, Sattur.

Dharwad
KARNATAKA
580009
India 
Phone  9731278744  
Fax    
Email  shwetasharda1989@gmail.com  
 
Source of Monetary or Material Support  
SHWETA SHARDA SDMCDSH, Room No. 10 Dharwad. 
 
Primary Sponsor  
Name  Shweta Sharda 
Address  SDM College of Dental Sciences and Hospital, Room No. 10, Dharwad. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shweta Sharda  SDMCDSH, Dharwad  Dept of Public Health Dentistry, Room No 10
Dharwad
KARNATAKA 		 9731278744

shwetasharda1989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMCDSH-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  plaque induced gingivitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.12% CHLORHEXIDINE  The patients were asked to brush their teeth using the given tooth paste and tooth brush in the advised manner only. After 30 minutes of brushing they were asked to take one table spoon (roughly 10 mL) of the allotted product, thoroughly rinse their mouth for 30 seconds and expectorate the mouthwash into the sink. The patients were asked to practice this twice a day – in the morning after waking up and at night just before sleeping. The subjects were recalled after 15 days and 30 days usage of the assigned products and were evaluated by the same calibrated dental examiner for gingival status using the same above mentioned index. The salivary neutrophil quantification was also done in a similar manner as stated above for the baseline evaluation. Data was recorded on the examination form. Soft tissue examination was also done to look for any adverse changes attributable to usage of products 
Intervention  HiOra Regular Herbal Mouthawash   The patients were asked to brush their teeth using the given tooth paste and tooth brush in the advised manner only. After 30 minutes of brushing they were asked to take one table spoon (roughly 10 mL) of the allotted product, thoroughly rinse their mouth for 30 seconds and expectorate the mouthwash into the sink. The patients were asked to practice this twice a day – in the morning after waking up and at night just before sleeping. The subjects were recalled after 15 days and 30 days usage of the assigned products and were evaluated by the same calibrated dental examiner for gingival status using the same above mentioned index. The salivary neutrophil quantification was also done in a similar manner as stated above for the baseline evaluation. Data was recorded on the examination form. Soft tissue examination was also done to look for any adverse changes attributable to usage of products 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  1. A minimum of 20 sound natural teeth with scorable facial and lingual surfaces.
2. Willingness to read, understand and sign the informed consent form.
3. Male and female subjects between 18-50 years in good general health.
4. Subject with good periodontal health with pockets < 6mm.
5. A gingival index score of ≥1.0.
6. A plaque index score of ≥1.5.
7. Availability for the entire study duration.
 
 
ExclusionCriteria 
Details  1. Destructive periodontal disease.
2. Significant soft tissue pathology, systemically related gingival enlargement / severe gingivitis.
3. History of diabetes, hepatic, renal disease or other serious medical condition and transmissible disease.
4. Orthodontic appliance or any kind of fixed or removable appliances.
Materials & Methods
5. History of allergies to dental products or their ingredients.
6. Pregnant and breast feeding women.
7. History of adverse habits like smoking and tobacco chewing.
8. Undergoing antibiotic, steroid therapy or any anti-inflammatory drugs in the preceding month.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingivitis - measured by Modified Loe and Silness Gingival index  15th day and 30th day post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Salivary Neutrophil Count  15th day and 30th day post intervention 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   12/08/2016 
Date of Study Completion (India) 29/09/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   This research study shall be sent for publication in relevant journal after being registered in CTRI. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background and Aim: Use of mouthwashes as an adjunct in the daily oral hygiene regimen has been strongly recommended by the dentists worldwide. Chlorhexidine has in fact been proven to be a gold standard in mouthwashes and is known to significantly reduce/prevent gingivitis. But owing to its side-effects of tooth discoloration and transient taste alteration on its long term use, there has been a constant effort to discover an equally efficient mouthwash with minimal or no side-effects. The aim of this study was to evaluate the effectiveness of a commercially available herbal mouthwash (Himalaya HiOra Regular) in comparison to 0.12% Chlorhexidine mouthwash in reducing gingivitis and salivary neutrophil count.

Methods and Materials: This study was a double blinded, randomized design. The herbal mouthwash (Himalaya HiOra Regular) was compared to 0.12% Chlorhexidine mouthwash (positive control).The patients gingival health status was evaluated using Gingival Index and Salivary Neutrophil Count (using Fluorescent Microscope) at baseline visit, 15th day and 30th day of intervention.

Results: Out of the 36 subjects randomized, none were lost to follow up and a total of  18 were analysed in Group A(Himalaya HiOra Regular Mouthwash) and 18 in Group B(0.12% Chlorhexidine). Both the groups showed a statistically significant reduction in Gingival Index Score ( Group A - 17%   & Group B - 14%   ) and in Salivary Neutrophil Counts (Group A -  35%  & Group B -32%). There was no significant difference in between the two groups both in the Gingival Scores ( ) and in the salivary neutrophil counts (  ).

Conclusions: This study has shown that herbal mouthwash is at par with the gold standard  in reducing gingivitis in a 4 week period. Thus herbal mouthwash forms a promising adjunct to the daily oral hygiene regimen with minimal/ no side effects reported.

 
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