| CTRI Number |
CTRI/2018/02/011660 [Registered on: 02/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This is a study to know the effectiveness of pomegranate (punica granatum) peel extract in the treatment of denture stomatitis |
|
Scientific Title of Study
|
Effectiveness of Punica granatum peel extract as an anti fungal agent in patients with Denture stomatitis - A randomized double blinded clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mahalakshmi |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental college |
| Address |
Room no. 1,
Department of Oral Medicine and Radiology,
Vishnu dental college ,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9441192725 |
| Fax |
08816250894 |
| Email |
vadladhi.mahalakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Jyothirmai |
| Designation |
Reader |
| Affiliation |
Vishnu Dental college |
| Address |
Department of Oral Medicine and Radiology,
Vishnu dental college ,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
08816250894 |
| Email |
jyothirmaik2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Jyothirmai |
| Designation |
Reader |
| Affiliation |
Vishnu Dental college |
| Address |
Department of Oral Medicine and Radiology,
Vishnu dental college ,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
08816250894 |
| Email |
jyothirmaik2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Vishnu college of pharmacy, Bhimavaram |
| Vishnu dental college, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Dr V Mahalakshmi |
| Address |
Department of Oral Medicine and Radiology,
Vishnu Dental college,
Vishnupur
Bhimavaram |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Mahalakshmi |
Vishnu dental college |
Room number-1
Department of Oral Medicine and Radiology
Vishnu dental college
Vishnupur,
Bhimavaram-534202
West Godavari
ANDHRA PRADESH |
9441192725
08816250894
vadladhi.mahalakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VISHNU INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances, Denture stomatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Miconazole 2% w/w gel |
Daktarin gel,
Janssen pharmaceuticals
Belgium |
| Intervention |
Punica granatum |
Punica granatum peel extract gel |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical and laboratory
(culture test) diagnosis as denture stomatitis. |
|
| ExclusionCriteria |
| Details |
1. Patient who are allergic to Punica granatum.
2. Patients who are under antifungal agents at the time of treatment or in last three months.
3. Patients on medication which could promote oral candidal colonization such as antibiotics.
4. Patients on treatment regimens such as chemotherapy and radiation therapy.
5. Patients with uncontrolled systemic illness.
6. Patients who are not willing for the treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in the erythema
2.Decrease in number of pin point hemorrhages
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
|
| Outcome |
TimePoints |
| 1.Decrease in burning sensation with visual analog scale |
1.Decrease in burning sensation with visual analog scale-day 1, 7,14 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/12/2016 |
| Date of Study Completion (India) |
14/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |