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
|
|
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
|
|
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. |