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CTRI Number  CTRI/2014/08/004844 [Registered on: 08/08/2014] Trial Registered Prospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a clinical trial to study the effects of 3 mouth rinses (aloe vera, chlorhexidine, chlorine dioxide)in patients undergoing dental braces treatment.  
Scientific Title of Study   EVALUATION OF ANTIPLAQUE AND ANTIGINGIVITIS EFFECT OF ALOE VERA, CHLORINE DIOXIDE AND CHLORHEXIDINE MOUTH RINSES: A RANDOMISED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Y Sravan Kumar 
Designation  post graduate 
Affiliation  Manipal College of Dental Sciences 
Address  Department of Public Health Dentistry Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  09035646224  
Fax    
Email  drsravanmdsphd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashidhar Acharya 
Designation  Professor and Head of Department  
Affiliation  Manipal College of Dental Sciences 
Address  Department of Public Health Dentistry Manipal College of Dental Sciences Manipal
Department of Public Health Dentistry Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India 
Phone  09448127031  
Fax    
Email  shashidhar_acharya@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Y Sravan Kumar 
Designation  post graduate 
Affiliation  Manipal College of Dental Sciences 
Address  Department of Public Health Dentistry Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  09035646224  
Fax    
Email  drsravanmdsphd@gmail.com  
 
Source of Monetary or Material Support  
Manipal college of dental sciences, Manipal 
 
Primary Sponsor  
Name  Dr Sravan Kumar Y  
Address  dept of public health dentistry manipal college of dental sciences manipal 
Type of Sponsor  Other [principal investigator] 
 
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 Sravan Kumar Y  manipal college of dental sciences  Department of orthodontics, PG division Room no - 7 manipal college of dental sciences manipal
Udupi
KARNATAKA 
9035646228

drsravanmdsphd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturaba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  gingivitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  aloe vera mouth rinse  Indigenous preparation of Aloe vera mouth rinse of 50 ug/ml will be dispensed in amber coloured bottles. route of administration is orally and for topical use only. clear instructions will be given to gargle not to swallow. all the participants under study will use the respected mouth washes for 15 days twice daily (morning & night. 
Comparator Agent  chlorhexidine mouth rinse  Commercially available 0.2% Chlorhexidine (Nitra hex, Micro Labs Limited, Bangalore, India) will be dispensed in amber coloured bottles. route of administration is orally and for topical use only. clear instructions will be given to gargle not to swallow. all the participants under study will use the respected mouth washes for 15 days twice daily (morning & night) 
Intervention  chlorine dioxide mouth rinse  Commercially available 0.1% Chlorine dioxide (Freshchlor, Group Pharmaceuticals, Mumbai, India) will be dispensed in amber coloured bottles. route of administration is orally and for topical use only. clear instructions will be given to gargle not to swallow. all the participants under study will use the respected mouth washes for 15 days twice daily (morning & night) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Patients visiting Department of Orthodontics, Manipal College of Dental Sciences, Manipal.
2.Systemically healthy patients.
3.Subjects willing to participate. 
 
ExclusionCriteria 
Details  1.Subjects with multiple restorations and gross dental caries on palatal, buccal and proximal surfaces.
2.Subjects under any form of topical or systemic antibiotic treatment during the past 2 weeks.
3.Subjects who are current users of tobacco in any form. 
 
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 
anti plaque efficacy of Aloe vera, Chlorine dioxide and Chlorhexidine mouth rinses   clinical evaluation will be done before and after 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
anti gingivitis efficacy of Aloe vera, Chlorine dioxide and Chlorhexidine mouth rinses   clinical evaluation will be done before and after 15 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/10/2014 
Date of Study Completion (India) 30/12/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Periodontal diseases (gingivitis and periodontitis) and dental caries are the two most prevalent oral infections affecting mankind worldwide and plaque is the common etiological factor. Plaque control is the basis and goal for prevention of gingivitis, periodontitis and dental caries. However, complete plaque removal is difficult to achieve and prevention can be achieved by reducing the quantity of plaque below the threshold level for disease or changing the quality of plaque towards more protective composition.

For effective plaque control, several mechanical (tooth brushing and flossing) and chemical oral hygiene aids are available. Among the various chemical antimicrobial agents available, Chlorhexidine is considered as gold standard. Chlorhexidine can be used as mouth rinse or gel, but has side effects such as staining of teeth and tongue, altered taste sensation and increased calculus formation over prolonged usage.

Recently, the extracts or oils of various medicinal plants having antimicrobial and anti-inflammatory activity has been reported and used for prevention of various oral infections. Aloe vera, is one such plant which was shown to have antimicrobial, anti-inflammatory, antiulcer activity and astringent effect. Considering the beneficial effects along with ease of availability, cost and no known adverse effects, Aloe vera can be a suitable alternative.

Recently a mouthwash containing Chlorine dioxide (ClO2) has become available on the market. Oral rinses containing ClO2 are utilized in dental practices as a topical antiseptic. Previous studies have suggested that ClO2 is bactericidal to most of the periodontogenic microorganisms and shown promising results.

The presence of fixed appliances in oral cavity for prolonged periods create favourable conditions for the development of dental plaque by providing retentive surface which increases the bacterial load. Hence, gingival inflammation and demineralization of enamel occurs more frequently in orthodontic patients with poor oral hygiene. Hence, there is a need for products for regular maintenance of acceptable oral hygiene without any adverse effects.

 Null Hypothesis: there is no difference in anti plaque and anti gingivitis efficacy of Aloe vera, Chlorine dioxide and Chlorhexidine mouth rinses among patients undergoing orthodontic treatment.

 
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