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

Orthodontic Appliance Complication Clinical Trial

Official title:

Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004196
• Other study ID #: CD-01
• 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
• 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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries
• Long Term Adverse Effects
• Orthodontic Appliance Complication
• White Spot Lesion of Tooth

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