Skip to main content
OpenTrials
Completed

NCT Number: NCT03004196

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peoples College Of Dental Science & Research Center

Bhopal, Madhya Pradesh, 462016, India

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Toothpaste

Drug

G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria

Other names: G.D Probiotic Toothpaste

Dr. Reddy's Clohex

Drug

0.20% Chlorhexidine Mouthwash

Other names: Chlorhexidine Mouthwash

Control Group

Other

No Probiotic toothpaste & Chlorhexidine Mouthwash

Primary outcomes

  1. Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash

    Time frame: 1 Month

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

Sponsors and collaborators

Lead sponsor

Peoples University, Bhanpur, Bhopal

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2016
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.