Topical Phenytoin for Management of Gingival Recession: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Clinical Attachment loss
研究概览
简要总结
Gingival recession (GR) is a term that describes the displacement of the gingival margin apical to the cemento-enamel junction (CEJ) of a tooth. The gold standard of GR treatment is surgical coverage through coronally advanced flap with subepithelial connective tissue graft (CAF+SCTG) (3). But, the need for a non-invasive technique for managing GR has not been frequently addressed.
Phenytoin (PHT), used as an anti-seizure medication, has an established side effect of causing drug-influenced gingival enlargement. Its stimulatory effects on soft tissue metabolism suggested PHT to be tested topically for its effectiveness in wound healing. However, none of the previous studies that investigated topical phenytoin has assessed gingival recession; except for a case series.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having gingival recession types RT1 and RT2
- •Patients refusing surgical treatment options of their gingival recession.
排除标准
- •Patients who underwent periodontal surgery in the affected teeth.
- •Patients with sensitivity to the medication used in the study.
- •Patients with systemic problems or administering drugs which could affect their periodontium or healing.
- •Pregnant or lactating women.
- •Smoking patients.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Phenytoin
干预措施: phenytoin cream (Drug)
结局指标
主要结局
Clinical Attachment loss
时间窗: 3 months
measured by Periodontal probe (distance from cemento-enamel junction to base of the pocket)
次要结局
- gingival recession(3 months)
- probing depth(3 months)
- gingival thickness(3 months)
- Keratinized tissue width(3 months)
- dentin hypersensitivity(3 months)