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Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans

Primary Purpose

White Spot Lesion of Tooth, Long Term Adverse Effects, Caries, Dental

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Probiotic Toothpaste
Dr. Reddy's Clohex
Control Group
Sponsored by
Peoples University, Bhanpur, Bhopal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for White Spot Lesion of Tooth focused on measuring White Spot Lesion, Probiotics, Chlorhexidine, Streptococcus Mutans, Fixed Orthodontic Treatment

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Peoples College Of Dental Science & Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Probiotic Group

Chlorhexidine Mouthwash Group

Arm Description

They were not given probiotic toothpaste or chlorhexidine mouthwash

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.

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.

Outcomes

Primary Outcome Measures

Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
Probiotic Toothpaste & Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group

Secondary Outcome Measures

Full Information

First Posted
December 2, 2016
Last Updated
December 22, 2016
Sponsor
Peoples University, Bhanpur, Bhopal
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1. Study Identification

Unique Protocol Identification Number
NCT03004196
Brief Title
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans
Official Title
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peoples University, Bhanpur, Bhopal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion of Tooth, Long Term Adverse Effects, Caries, Dental, Orthodontic Appliance Complication
Keywords
White Spot Lesion, Probiotics, Chlorhexidine, Streptococcus Mutans, Fixed Orthodontic Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
They were not given probiotic toothpaste or chlorhexidine mouthwash
Arm Title
Probiotic Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Chlorhexidine Mouthwash Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Probiotic Toothpaste
Other Intervention Name(s)
G.D Probiotic Toothpaste
Intervention Description
G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria
Intervention Type
Drug
Intervention Name(s)
Dr. Reddy's Clohex
Other Intervention Name(s)
Chlorhexidine Mouthwash
Intervention Description
0.20% Chlorhexidine Mouthwash
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
No Probiotic toothpaste & Chlorhexidine Mouthwash
Primary Outcome Measure Information:
Title
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
Description
Probiotic Toothpaste & Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Chandrika Dubey, MDS
Organizational Affiliation
Peoples University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peoples College Of Dental Science & Research Center
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462016
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23810047
Citation
Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.
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Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans

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