This is a study to know the effectiveness of pomegranate (punica granatum) peel extract in the treatment of denture stomatitis

Not Applicable

Completed

• Conditions: Abnormal findings in other body fluids and substances, Denture stomatitis,

• Registration Number: CTRI/2018/02/011660
• Lead Sponsor: Dr V Mahalakshmi

Brief Summary

The study is randomized double blinded, parallel group active control trial to test the effectiveness of  anti fungal properties of the phyto chemical, Punica granatum peel extract in comparison with miconazole 2%  in the patients with denture stomatitis that is conducted in Vishnu dental college, Bhimavaram, India. the primary outcome measures will be reduction in erythema,decrease in number of pin point hemorrhages, decrease in burning sensation by visual analog scale, decrease in number of fungal hyphae at day 0, day 1, day 7, day 14.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-12
• Study Completion: 2018-06-14
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with clinical and laboratory (culture test) diagnosis as denture stomatitis.

Exclusion Criteria

• Patient who are allergic to Punica granatum.
• Patients who are under antifungal agents at the time of treatment or in last three months.
• Patients on treatment regimens such as chemotherapy and radiation therapy.
• Patients who are not willing for the treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Decrease in number of pin point hemorrhages	1. Reduction in the erythema-day 0 | 2. Decrease in number of pin point hemorrhages-day 1, 7, 14. | 3. Reduction in the number of fungal hyphae-day 0, 1, 7, 14
1.Reduction in the erythema	1. Reduction in the erythema-day 0 | 2. Decrease in number of pin point hemorrhages-day 1, 7, 14. | 3. Reduction in the number of fungal hyphae-day 0, 1, 7, 14
3.Reduction in the number of fungal hyphae	1. Reduction in the erythema-day 0 | 2. Decrease in number of pin point hemorrhages-day 1, 7, 14. | 3. Reduction in the number of fungal hyphae-day 0, 1, 7, 14

Secondary Outcome Measures

Name	Time	Method
1.Decrease in burning sensation with visual analog scale	1.Decrease in burning sensation with visual analog scale-day 1, 7,14

Trial Locations

Locations (1)

Vishnu dental college; 🇮🇳 Godavari, ANDHRA PRADESH, India

Vishnu dental college

🇮🇳Godavari, ANDHRA PRADESH, India

Dr V Mahalakshmi

Principal investigator

9441192725

vadladhi.mahalakshmi@gmail.com