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CTRI Number  CTRI/2018/05/013986 [Registered on: 21/05/2018] Trial Registered Retrospectively
Last Modified On: 10/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To clinically evaluate different types of mouthwashes in swollen gums  
Scientific Title of Study   Comparative evaluation of Triphala, Aloevera and Chlorhexidine mouthwash on Gingivitis: A randomized placebo-controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vivek Bypalli 
Designation  Post graduate student 
Affiliation  Vishnu Dental College 
Address  Vishnu dental college,Vishnupur, Bhimavaram, West godavari district

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9640166656  
Fax    
Email  vivek.baipalli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gautami S Penmetsa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Vishnu dental college,Vishnupur, Bhimavaram, West godavari district

West Godavari
ANDHRA PRADESH
534 202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gautami S Penmetsa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Vishnu dental college,Vishnupur, Bhimavaram, West godavari district

West Godavari
ANDHRA PRADESH
534 202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Source of Monetary or Material Support  
vishnu dental college, Bhimavaram 
 
Primary Sponsor  
Name  PI 
Address  department of periodontics and implantology, block 2, vishnu dentalcollege,bhimavaram. 
Type of Sponsor  Other [private dental college] 
 
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 
vivekbypalli  Vishnu Dental College  department of periodonticsand implantology, block 2,room number 7, bhimavaram.
West Godavari
ANDHRA PRADESH 
9640166656

vivek.baipalli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commite  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aloevera  Aloe vera or Aloe barbadensis miller (family Liliaceae) is a tropical plant easily grown in hot and dry climates of Africa, Asia, America and Europe. it is antiinflammatory, antibacterial, antifungal, antiviral, wound healing, pain relief. Advised 10ml twice daily for 30 days.  
Intervention  chlorhexidine  chlorhexidine is an antimicrobial agent.it prevents plaque accumulation. Hence it is a antiplaque and antigingival agent. Advised 10ml twice daily for 30days. 
Comparator Agent  Triphala  TRP is considered a traditional Ayurvedic medicine made from fruits of three medicinal trees: Amalaki (Emblica officinalis) Bibhitaki (Terminalia belerica) Haritaki (T. chebula) It has antibacterial and antiseptic properties, and anti-inflammatory action. Advised 10ml of mouthwash twice daily for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  age groups of 18-40 years with chronic generalized gingivitis.
Minimum of 20 teeth in the mouth.
No periodontal treatment was done in last 6 months.
 
 
ExclusionCriteria 
Details  poor oral hygiene
Pregnancy and lactating women
Patients on antibiotic therapy for last 1 month.
Smokers
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
gingival index,bleeding index  Baseline,15 days,30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index  Baseline,15 days,30 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   02/01/2017 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 Dental plaque is associated with the most prevalent oral diseases like dental caries and periodontal diseases. The removal of plaque is a determining component in the prevention of these diseases. The use of mechanical agents is a simple and cost effective method that has been demonstrated to be effective in control of gingivitis. Most of the individuals do not practice an acceptable standard of mechanical plaque removal due lack of dexterity in performing oral hygiene methods.                                  
  Aloe barbadensis, also known as aloevera, has the greatest medicinal value. Aloevera was regarded as the most effective for general therapeutic and medicinal uses. The parenchymal tissue makes up the inner portion of Aloe leaves and produces a clear, thin, tasteless, jelly-like material called Aloevera gel. The gel contains approximately 98.5% water, with the remaining 0.5–1% solid material consisting of a wide range of compounds including vitamins A, C and E. Vitamin B1 (thiamine), niacin, vitamin B2 (riboflavin), choline, folic acid, traces of vitamin B12 and enzymes such as acid phosphatase, alkaline phosphatase, amylase, lactic dehydrogenase and lipase. The purpose of the study is to evaluate the efficacy of the aloevera in treatment of gingivitis. 
 
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