A clinical trial to find out the effectiveness of probiotics added to denture sticking powder in reducing fungal infection inside the oral cavity in a denture wearing patient and its effect on retention of the denture.

Phase 2

Active, not recruiting

• Conditions: Other forms of stomatitis,

• Registration Number: CTRI/2017/04/008314
• Lead Sponsor: Tamanna M Chhabra

Brief Summary

This study is a randomised controlled trial with a cross over design to find out the effect of probiotics added to denture adhesives on the colony forming units of candida in the oral cavity in complete denture wearers and its effect on retention of the denture . It has been proved that probiotics bring down the candida infection level  in oral cavity in complete denture patients.A trial product was generated where probiotics of the total power of 10raise to power 8 containing lactobacillus rhamnosus,lactobacillus acidophilus and bifidobacterium bifidum. the primary outcome assessed will be CFU/uL and retention in Complete denture patients in N-Cm.  Candida is a normal commensal of the oral cavity but it can become can turn pathogenic in patients who are immunocompromised.Denture adhesives enhance retention in the dentures.Therefore they are commonly prescribed in denture wearing patients. It has also been shown that denture adhesives can increase the risk of candida in denture wearing patients if they do not maitain hygiene adequately. therefore there was need to generate a product which can enhance the retention of the denture at the same time prevent candida growth under the denture in healthy and in immunocompromised patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• a.Completely edentulous patients b.
• Patients who will be not using antibiotics, antifungals or probiotics in any form.
• Patients who will be asymptomatic candida carriers in oral cavity d.
• Patients who will understand and will be ready to be part of the study.

Exclusion Criteria

• Patients suffering from any chronic debilitating disorder b.
• Inability to understand and be part of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Colony forming unit of candida CFU/ul	5 weeks
2. Retention of upper denture N-cm	5 weeks

Secondary Outcome Measures

Name	Time	Method
there are no secondary outcomes	there are no secondary outcomes

Trial Locations

Locations (1)

K M Shah Dental College and Hospital; 🇮🇳 Vadodara, GUJARAT, India

K M Shah Dental College and Hospital

🇮🇳Vadodara, GUJARAT, India

Tamanna M Chhabra

Principal investigator

8758868392

drtamannachhabra@gmail.com