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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03004196
Other study ID # CD-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 2, 2016
Last updated December 22, 2016
Start date September 2015
Est. completion date October 2015

Study information

Verified date December 2016
Source Peoples University, Bhanpur, Bhopal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Probiotic Toothpaste
G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria
Dr. Reddy's Clohex
0.20% Chlorhexidine Mouthwash
Other:
Control Group
No Probiotic toothpaste & Chlorhexidine Mouthwash

Locations

Country Name City State
India Peoples College Of Dental Science & Research Center Bhopal Madhya Pradesh

Sponsors (1)

Lead Sponsor Collaborator
Peoples University, Bhanpur, Bhopal

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash Probiotic Toothpaste & Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group 1 Month
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