EVALUATION OF SAFETY AND EFFICACY OF FOLICACID GEL IN THE TREATMENT OF PERIODONTAL DISEASE
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical outcome measures
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Bleeding on Probing more than 40 percent in at least two different quadrants.
排除标准
- •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.
- •Pregnant and Lactating Females.
- •4.Obesity
- •Tobacco and Alchohol Consumption.
结局指标
主要结局
Clinical outcome measures
时间窗: 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
1. Plaque Index(PI)
时间窗: 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
2. Bleeding on Probing (BOP)
时间窗: 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
1. Complete Blood Count
时间窗: 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
2. Renal and Liver Function Test
时间窗: 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
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.
时间窗: 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
4. Clinical Attachment level(CAL)
时间窗: 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
3. Probing Pocket Depth (PPD)
时间窗: 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
Laboratory paramaters
时间窗: 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
3. Serum Folic acid levels
时间窗: 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
Safety monitoring :
时间窗: 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
次要结局
- Serum C reactive protein(Baseline and 6 weeks post intervention.)