| CTRI Number |
CTRI/2018/03/012813 [Registered on: 23/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of folic acid on red,burning
and ulcerated gums |
|
Scientific Title of Study
|
Effect of Folic acid supplementation on Desquamative gingivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saif Khan |
| Designation |
Assistant Professor |
| Affiliation |
Aligarh Muslim University Aligarh |
| Address |
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
919012875280 |
| Fax |
|
| Email |
saifgood@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saif Khan |
| Designation |
Assistant Professor |
| Affiliation |
Aligarh Muslim University Aligarh |
| Address |
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh
UTTAR PRADESH
202002
India |
| Phone |
919012875280 |
| Fax |
|
| Email |
saifgood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saif Khan |
| Designation |
Assistant Professor |
| Affiliation |
Aligarh Muslim University Aligarh |
| Address |
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh
UTTAR PRADESH
202002
India |
| Phone |
919012875280 |
| Fax |
|
| Email |
saifgood@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Periodontics and Community Dentistry Dr Z A Dental College Aligarh Muslim University Aligarh |
|
|
Primary Sponsor
|
| Name |
Dr Saif Khan |
| Address |
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Saif Khan |
Dept of Periodontics and Community Dentistry Dr Z A Dental College AMU Aligarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saif Khan |
Dr Z A Dental College and Hospital, Aligarh Muslim University,Aligarh,UP |
Dept of Perioodntics and Community Dentistry
OPD No 2
Aligarh
UTTAR PRADESH |
9012875280
saifgood@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Faculty of Medicine,AMU,Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Desquamative Gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral supplementation of tablet Folic acid 5mg once daily for 2weeks as an adjunct along with topical local steroid twice daily for 2 weeks. |
Tablet Folic acid 5mg once daily as adjunct to
local application of kenacort(0.1% Triamcinolone acetonide Oromucosal paste)by finger twice daily for 2 weeks |
| Comparator Agent |
Topical local steroid twice daily for 2 weeks.(active control) |
local application of Kenacort (0.1% Triamcinolone acetonide Oromucosal paste) by finger twice daily morning and before bedtime for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Desquamative Gingivitis Lesion presenting as erythema, burning sensation, desquamation, ulceration of gingiva and associated oral mucosa |
|
| ExclusionCriteria |
| Details |
Dental plaque induced inflammatory diseases of gingiva such as gingivitis and periodontitis.
Oral Candidiasis.
Acute Herpetic gingivostomatitis.
Acute Necrotizing ulcerative gingivitis. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Healing outcome of the lesion(Complete regression/partial regression/No Regression)
2.Change in the surface area of the lesion(mm2)
3. Visual analog score for assessing reduction in pain perception(0 to 10 scale)
|
Baseline, 2 weeks post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque Index
Gingival Index
Bleeding on Probing(BOP)
Salivary TNF-alpha Levels
|
Baseline, 2 weeks postintervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="7"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Desquamative gingivitis (DG) is a non-plaque induced lesions of the oral mucosa, characterised by erythema, erosion, desquamation of the gingival and associated oral mucosa .These lesions are quite unpredictable in their clinical course and are quite challenging for the clinician to treat, as sometimes they are refractory to current standard therapeutic modality. Folic acid is one of the vitamin B complex, acts as co factor in DNA methylation which is essential for DNA synthesis and repair.Evidence has shown that folic acid supplementation plays important role in chemoprevention of gastric carcinogenesis by increasing epithelial apoptosis in premalignant lesions by up regulating P53 gene and down regulating Bcl-2 gene. It has been shown in double-blind randomized trials that folic acid both in systemic supplementation and local delivery increased the resistance of gingival cells to local irritants and decreased gingival inflammation .In the light of above evidence we propose to study the effect of Folic acid supplementation on DG with the objective to compare the clinical outcomes and salivary TNF-alpha levels in DG patients receiving standard local steroid therapy versus standard local steroid therapy with adjunct systemic oral folic acid supplementation. |