- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03004196
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care.
These bacteria metabolize different kind of carbohydrates accumulated around orthodontic appliances and create acidic environment in the oral cavity leading to enamel demineralization around the brackets and white spot lesions.
This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are not using them.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where plaque gets accumulated, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions. Probiotics act by competitively inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental plaque around orthodontic appliances. AIM & OBJECTIVE - The objectives of the study is to evaluate and compare the effects of the topical application of probiotic toothpaste and chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic patients hence improving the oral micro-flora of oral cavity by competitive inhibition of Streptococcus Mutans in plaque present around brackets.
MATERIAL & METHOD - The study consists of thirty randomly selected orthodontic patients undergoing fixed appliance treatment. The patients were divided into three groups - Control Group (Group 1), Probiotic Toothpaste Group (Group 2) & Chlorhexidine Mouthwash Group (Group 3). Samples were collected at two times interval: before the study began (Phase 1) and after thirty days (Phase 2).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Madhya Pradesh
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Bhopal, Madhya Pradesh, India, 462016
- Peoples College Of Dental Science & Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek, Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)
- Good General Health (No Significant Medical History Or Drug Use During The Last Month)
- No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study
- No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study
- Habit Of Brushing Twice Daily With Fluoride Toothpaste
Exclusion Criteria:
-Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control Group
They were not given probiotic toothpaste or chlorhexidine mouthwash
|
No Probiotic toothpaste & Chlorhexidine Mouthwash
|
EXPERIMENTAL: Probiotic Group
Patients were asked to brush twice daily with given "G.D Probiotic Toothpaste" and were asked not to eat or drink anything for half-an-hour.
|
G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria
Other Names:
|
EXPERIMENTAL: Chlorhexidine Mouthwash Group
Patients were asked to rinse daily with "Dr.
Reddy's Clohex" chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour.
|
0.20% Chlorhexidine Mouthwash
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
Time Frame: 1 Month
|
Probiotic Toothpaste & Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group
|
1 Month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr.Chandrika Dubey, MDS, Peoples University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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