CTRI

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CTRI Number

CTRI/2023/11/059535 [Registered on: 06/11/2023] Trial Registered Prospectively

Last Modified On:

14/09/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Dentistry
Nutraceutical

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Use of Folic acid gel in Gum Diseases.

Scientific Title of Study

EVALUATION OF SAFETY AND EFFICACY OF FOLIC ACID GEL IN THE TREATMENT OF PERIODONTAL DISEASE

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
Address	Department of Periodontics and Community Dentistry Dr Ziauddin Ahmad Dental College and Hospital Faculty of Medicine Aligarh Muslim University Aligarh Department of Periodontics and Community Dentistry Dr Ziauddin Ahmad Dental College AMU Aligarh UTTAR PRADESH 202002 India
Phone	9012875280
Fax
Email	saifgood@gmail.com

Details of Contact Person
Scientific Query

Name	Dr SAIF KHAN
Designation	Assistant Professor
Affiliation	Aligarh Muslim University
Address	Department of Periodontics and Community Dentistry Dr Ziauddin Ahmad Dental College and Hospital Faculty of Medicine Aligarh Muslim University Aligarh Department of Periodontics and Community Dentistry Dr Ziauddin Ahmad Dental College AMU UTTAR PRADESH 202002 India
Phone	9012875280
Fax
Email	saifgood@gmail.com

Details of Contact Person
Public Query

Name	Dr Najmus Sahar
Designation	Junior Resident
Affiliation	Aligarh Muslim University
Address	Department of Periodontics and Community Dentistry Dr Ziauddin Ahmad Dental College and Hospital Faculty of Medicine Aligarh Muslim University Aligarh Department of Periodontics and Community Dentistry Dr Ziauddin Ahmad Dental College AMU Aligarh UTTAR PRADESH 202002 India
Phone	917017270123
Fax
Email	najmus0786@gmail.com

Source of Monetary or Material Support

Department of Periodontics Dr Ziauddin Ahmad Dental College and Hospital Aligarh Muslim University Aligarh UP

Primary Sponsor

Name	Aligarh Muslim University Aligarh
Address	Department of Periodontics Dr Z A Dental College and Hospital Faculty of Medicine Aligarh Muslim University Aligarh UP
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

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 Ziauddin Ahmad Dental College and Hospital Aligarh Muslim University Aligarh	Department of Periodontics OPD 2 Aligarh UTTAR PRADESH	919012875280 0572721184 saifgood@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital Faculty of Medicine AMU Aligarh	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: A488\|\|Other specified bacterial diseases, (2) ICD-10 Condition: B999\|\|Unspecified infectious disease,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Folic acid gel (0.05%)	Non surgical periodontal therapy with adjunct 0.05% Folic acid gel as local drug delivery agent.
Intervention	Folic acid gel (0.1%)	Non surgical periodontal therapy with adjunct 0.1% Folic acid gel as local drug delivery agent
Comparator Agent	Placebo gel.	Non surgical periodontal therapy with adjunct placebo gel as local drug delivery agent.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	1.Patients aged 18 to 40 years with established periodontal disease with more than 20 teeth 2.Having at least 3 to 4 periodontal pockets with periodontal pocket depth more than 4 mm 3. Bleeding on Probing more than 40 percent in at least two different quadrants

ExclusionCriteria

Details

1.Periodontal disease patient who received periodontal treatment within the previous year, or an anti-inflammatory or antimicrobial therapy or iron/vitamin supplement (s) within the previous three months.
2.systemic conditions including diabetes, immunodeficiency, malignancy, bone metabolic diseases/disorders, renal or thyroid dysfunction, radiation or immunosuppressive therapy and gastrointestinal diseases.
3. Pregnant and Lactating Females.
4.Obesity
5. Tobacco and Alchohol Consumption.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome

TimePoints

Clinical outcome measures
1. Plaque Index(PI)
2. Bleeding on Probing (BOP)
3. Probing Pocket Depth (PPD)
4. Clinical Attachment level(CAL)
Laboratory paramaters
1. Complete Blood Count
2. Renal and Liver Function Test
3. Serum Folic acid levels
Safety monitoring :
Any local or systemic adverse drug reaction will be reported in accordance with ADR format of Indian Pharmacopoeia Comission following gel application at 24-48 hours, between 1-2 weeks and between 4-6 weeks.

Clinical outcome measures at Baseline, 4 weeks postintervention, 6 weeks post intervention follow-up
Laboratory investigations CBC,RFT,LFT at Baseline and 6 weeks post intervention follow up
Serum Folic acid levels at Baseline, 2 hours after gel application, 2 weeks after gel application

Secondary Outcome

Outcome	TimePoints
Serum C reactive protein	Baseline and 6 weeks post intervention.

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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)

20/11/2023

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="0"
Months="11"
Days="15"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details
Modification(s)

None Yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

Folic acid deficiency causes impaired epithelial integrity and barrier functions in the oral mucosa, as well as increased nuclear staining in the basal cells as well as degeneration and widening of intracellular spaces in the spinous layer. The oral mucosa is predisposed to infection and ulceration due to epithelial abnormalities in the various stages of maturation and keratinization. Furthermore, there is a decrease in blood cell function which increases the risk of stomatitis, gingivitis, periodontitis and poor healing outcomes.

In wound models in rats and diabetic mice, use of topical folic acid has been found to accelerate epithelialization, inflammatory cell migration and collagen deposition all of which enhances the kinetics of wound healing. Folic acid supplementation has been demonstrated to enhance gingival resistance to local irritants and reduce gingival inflammation. Also, folic acid mouth rinse promotes gingival health through local rather than systemic administration Based on evidence of folic acid wound healing promotional properties, the present study is designed to evaluate the safety and efficacy of intra oral topical application of 0.1% folic acid and to compare its effects with 0.05% folic acid and placebo gel as an adjunct to non surgical periodontal therapy in treatment of periodontal disease.