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

NCT03004196 | Completed Phase 1

• 1 other identifier: CD-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash

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

  1 Month

Study Arms (3)

Control Group

ACTIVE COMPARATOR

They were not given probiotic toothpaste or chlorhexidine mouthwash

Other: Control Group

Probiotic Group

EXPERIMENTAL

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.

Drug: Probiotic Toothpaste

Chlorhexidine Mouthwash Group

EXPERIMENTAL

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.

Drug: Dr. Reddy's Clohex

Interventions

Probiotic Toothpaste DRUG

G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria

Also known as: G.D Probiotic Toothpaste

Probiotic Group

Dr. Reddy's Clohex DRUG

0.20% Chlorhexidine Mouthwash

Also known as: Chlorhexidine Mouthwash

Chlorhexidine Mouthwash Group

Control Group OTHER

No Probiotic toothpaste \& Chlorhexidine Mouthwash

Control Group

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc

Sponsors & Collaborators

• Peoples University, Bhanpur, Bhopal: lead

Study Sites (1)

Peoples College Of Dental Science & Research Center

Bhopal, Madhya Pradesh, 462016, India

Location

Related 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.

  PMID: 23810047 BACKGROUND

MeSH Terms

Conditions

Long Term Adverse Effects; Dental Caries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dr.Chandrika Dubey, MDS

  Peoples University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Graduate Student

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 28, 2016
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)