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CTRI Number  CTRI/2018/06/014686 [Registered on: 29/06/2018] Trial Registered Prospectively
Last Modified On: 26/06/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ability of a polyherbal formulation to treat gum inflammation and Bad breath over a period of three months 
Scientific Title of Study   Effectiveness of a polyherbal formulation to treat gingivitis over a period of three months: A randomized trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Samuel Raj 
Designation  Senior Lecturer 
Affiliation  Thai Moogambigai Dental College and Hospital 
Address  Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Chennai
TAMIL NADU
600107
India 
Phone  7010395428  
Fax    
Email  samuelrajsrinivasan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Samuel Raj 
Designation  Senior Lecturer 
Affiliation  Thai Moogambigai Dental College and Hospital 
Address  Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Chennai
TAMIL NADU
600107
India 
Phone  7010395428  
Fax    
Email  samuelrajsrinivasan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Samuel Raj 
Designation  Senior Lecturer 
Affiliation  Thai Moogambigai Dental College and Hospital 
Address  Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Chennai
TAMIL NADU
600107
India 
Phone  7010395428  
Fax    
Email  samuelrajsrinivasan@gmail.com  
 
Source of Monetary or Material Support  
Dr. M.G.R. Educational and Research Institute University 
 
Primary Sponsor  
Name  Dr MGR educational and Research Institute University 
Address  Thai Moogambigai Dental College and Hospital, Chennai- 600107 
Type of Sponsor  Research institution 
 
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 Samuel Raj Srinivasan  Thai Moogambigai Dental College and Hospital  Public Health Dentistry, Thai Moogambigai Dental College and Hospital , Chennai- 107
Chennai
TAMIL NADU 
7010395428

samuelrajsrinivasan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. M.G.R Educational Research Institute University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  gingivitis and halitosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Colgate toothpaste (Triclosan)  Triclosan containing toothpaste to treat gingivitis and halitosis to be used twice daily (morning and night) for a period of three months  
Intervention  Polyherbal paste formulation  Haritaki, vibhitaki, amalaki, yasthimadu, sonth, kalimirch, pippili, vat vriksha, babbula, sonf are pulverized and added in specific concentrations of 5g/100gm of toothpaste to be used twice daily (morning and night) for a period of three months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients suffering from moderate to severe gingivitis and malodor of oral origin.
Those providing consent to participate and willing to be available for followup for 3 months 
 
ExclusionCriteria 
Details  Systemic diseases, oral malodor from extra oral origin and those allergic to any constituents of toothpaste are excluded.
Those not willing to provide consent and not available for followup for three months are excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in gingivitis and halitosis over a period of three months  30, 60, 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in plaque microbial load, total salivary bacterial load and total protein content  30, 60 and 90 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/07/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Common oral health problems like gingivitis, halitosis and dentinal hypersensitivity affect all people irrespective of age, gender and race. These conditions in particular affect the quality of life of the individual almost on a daily basis. In south India, studies report a prevalence of gingivitis to be 57%, and 47% from halitosis respectively. A plethora of treatment options are available to alleviate these conditions ranging from professional intervention to home care solutions, but individuals by majority opt for home care remedies. The principal home care remedy for the treatment of such common oral problems is dentifrice.

Medicated dentifrice containing chemicals such as triclosan or chlorhexidine is the gold standard for treating gingivitis and halitosis. They have their own merits but also causes tooth staining, taste alterations and rare instances mucosal desquamation and microbial resistance owing to prolonged use. Further, not much has been explored regarding a suitable herbal alternative towards the treatment of dentinal hypersensitivity.

Recent focus has shifted to the anti-inflammatory and antimicrobial properties of natural products, because of the widespread microbial resistance as a consequence of drug overuse. Several plants with herbal properties were identified through literature search and used through centuries by our forefathers to treat several oral conditions. The principal ingredients included in the phytotheraputic paste contain Terminalia chebula, Phylathus embelica, Terminalia belerica, Glycyrrhiza glabra, Acmella oleracea, Salvadora perscia, Ficus benghalensis among others.

We intend to check the effectiveness of a poly herbal paste formualtion with the aforementioned components to treat conditions such as gingivitis and halitosis. 


Aim: to evaluate the effectiveness of a polyherbal formulation to treat gingivitis and halitosis over a period of three months: A randomized controlled trial.

 
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