Use of Folic acid gel in Gum Diseases.

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059535

Enrollment

Registered

2023-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A488- Other specified bacterial diseases Health Condition 2: B999- Unspecified infectious disease

Interventions

Intervention1: Folic acid gel (0.1%): Non surgical periodontal therapy with adjunct 0.1% Folic acid gel as local drug delivery agent Intervention2: Folic acid gel (0.05%): Non surgical periodontal the

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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	—

Measure

Time frame

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.Timepoint: 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

Measure	Time frame
Serum C reactive proteinTimepoint: Baseline and 6 weeks post intervention.	—

Countries

India

Contacts

Public ContactDr Najmus Sahar

Aligarh Muslim University

saifgood@gmail.com9012875280

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026