| 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
|
|
|
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
|
|
|
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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