se of Folic acid gel in Gum Diseases.
- Conditions
- Health Condition 1: A488- Other specified bacterial diseasesHealth Condition 2: B999- Unspecified infectious disease
- Registration Number
- CTRI/2023/11/059535
- Lead Sponsor
- Aligarh Muslim University Aligarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome measures <br/ ><br>1. Plaque Index(PI) <br/ ><br>2. Bleeding on Probing (BOP) <br/ ><br>3. Probing Pocket Depth (PPD) <br/ ><br>4. Clinical Attachment level(CAL) <br/ ><br>Laboratory paramaters <br/ ><br>1. Complete Blood Count <br/ ><br>2. Renal and Liver Function Test <br/ ><br>3. Serum Folic acid levels <br/ ><br>Safety monitoring : <br/ ><br>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 <br/ ><br>Laboratory investigations CBC,RFT,LFT at Baseline and 6 weeks post intervention follow up <br/ ><br>Serum Folic acid levels at Baseline, 2 hours after gel application, 2 weeks after gel application
- Secondary Outcome Measures
Name Time Method Serum C reactive proteinTimepoint: Baseline and 6 weeks post intervention.