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CTRI Number  CTRI/2021/07/035292 [Registered on: 30/07/2021] Trial Registered Prospectively
Last Modified On: 29/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on the effects of herbal and non herbal toothpastes on health of gums and saliva  
Scientific Title of Study   Effects of commercially available herbal and non-herbal dentrifices on plaque, gingivitis and salivary pH: A clinico-biochemical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenakshi Verma  
Designation  Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614

Mumbai
MAHARASHTRA
400614
India 
Phone  9819626512  
Fax    
Email  mverma9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meenakshi Verma  
Designation  Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614


MAHARASHTRA
400614
India 
Phone  9819626512  
Fax    
Email  mverma9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Meenakshi Verma  
Designation  Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614


MAHARASHTRA
400614
India 
Phone  9819626512  
Fax    
Email  mverma9@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Dental college and Hospital, Navi Mumbai 
Dr Meenakshi Verma 
 
Primary Sponsor  
Name  Dr Meenakshi Verma 
Address  Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 
Type of Sponsor  Other [Self] 
 
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 Meenakshi Verma  Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai   Room no 402, Department of Periodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai.
Mumbai
MAHARASHTRA 
9819626512

mverma9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K050||Acute gingivitis, (2) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Colgate Dental Cream dentrifice  A group of subjects will be given Colgate Dental Cream dentrifice to use. All Subjects will be instructed to brush their teeth for 3 min 2 times a day for 4 weeks with Modified Bass method using the given toothpaste and will be recalled after 4 weeks following which the same clinical parameters will be reassessed (4 weeks score) 
Intervention  Himalaya Complete care dentrifice  A group of subjects will be given Himalaya Complete care dentrifice to use. All Subjects will be instructed to brush their teeth for 3 min 2 times a day for 4 weeks with Modified Bass method using the given toothpaste and will be recalled after 4 weeks following which the same clinical parameters will be reassessed (4 weeks score) 
Intervention  Sudanta dentrifice  A group of subjects will be given Sudanta dentrifice to use. All Subjects will be instructed to brush their teeth for 3 min 2 times a day for 4 weeks with Modified Bass method using the given toothpaste and will be recalled after 4 weeks following which the same clinical parameters will be reassessed (4 weeks score) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Adult patients >18 years of age and up to 40 years of age
Patients of both the gender
Selected subjects must have at least 20 natural teeth
Gingival index ≥ 1
Plaque index ≥ 2
Provide written informed consent
Willing and able to understand and comply with all study requirements

 
 
ExclusionCriteria 
Details  Patients with periodontitis
Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
Pregnant and lactating women
Smokers and tobacco in any form
Patients using antibiotics or anti-inflammatory drugs in the past 3 months
Patients using additional oral hygiene aids in the past 3 months
Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
Not willing to provide written informed consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index  Baseline, 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival Index  Baseline, 28 days 
Salivary pH  Baseline, 28 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   02/08/2021 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Presence of plaque is one of the main etiological factor for gingivitis, periodontitis, dental caries and halitosis. Plaque control can be achieved with the help of mechanical and chemical aids such as toothbrushes, dental floss, mouth rinses and dentifrices. Despite the efficacy of many chemical dentifrice formulations with antibacterial properties, there is an increasing social desire to rely on naturally occurring compounds for health, which has also found its way into dentistry. This has led to dentifrices that contain extracts of medicinal plants and herbs becoming popular. Consumers who gravitate towards using herbal products often view them as being safer than those that contain chemicals. The efficacy of such dentifrices can be attributed to properties such as anti- inflammatory, anti-microbial, anti-diabetic, anti-fungal, analgesic, antiseptic and astringent actions. Salivary pH, also plays an important role in maintaining oral health, and has an influence on the caries process. Demineralization and remineralization process of the tooth are dependent on pH of saliva, but available literature on scientific studies assessing the effect of non-herbal as well as herbal toothpastes on salivary pH are very few . Lack of professional consensus regarding use of herbal dentifrices due to lack of sufficient clinical research and literature has inspired us to undertake this clinical study. The objective of this study is to investigate the effects of two herbal dentifrices (Sudanta® and Himalaya Complete Care® Toothpaste) in controlling plaque and gingivitis and their effect on salivary pH as compared to conventional dentifrice (Colgate Dental Cream®). 

 
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