A randomized prospective split-mouth clinical study to compare the post-operative analgesic and anti-inflammatory effect of diclofenac sodium (0.074% mouthwash or 50mg tablets) after periodontal flap surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diclofenac sodium local application (0.074% mouthwash) will have equal analgesic effect as compared to its systemic administration (tablet), but it would be better in terms of its anti-inflammatory effect and patient’s acceptability when used after periodontal flap surgery.
研究概览
简要总结
All the patients will bescreened for periodontal findings. Sites meeting the inclusion criteria will be considered for the present study.This study is designed as randomized prospective split-mouth clinical trial.
In test group patients will be given0.074% diclofenac sodium mouthwash to be used at home for four days. Patientsin this group need to use the mouthwash for 1 min, twice daily for 4 days,starting one immediately after surgery. Test group patients will alsoprescribed diclofenac sodium 50mg tablet to be used if pain is not controlledby diclofenac mouthwash alone. Number of tablets used by the patient (if any)will also be recorded on their proforma sheet. In control group, patient willbe prescribed diclofenac sodium 50mg tablet twice daily for 4 days startingimmediately after surgery.
Randomizationwith regard to the choice of quadrant and choice of drug formulation (mouthwashor tablet) will be done by coin toss method. At least 15 days gap will bemaintained for second surgery in contralateral side when mode of therapy willbe switched.
Clinicalparameters will be checked at baseline, 7 days after surgery 1 month and 3months after surgery. Pain perception of patient will be scored using NumericalRating Scale. Data will be collected telephonically in the evening daily for 4days. Along with that patient will be given ‘Wong Baker scale’ score sheet tooand will be asked to fill it in the evening daily for 4 days. No perio dressingwill be placed after surgery in either group. At 7 days follow-up patient willbe asked about the acceptability of the mouthwash. At last follow-up of secondsurgery, patient will be asked about their personal preference betweenmouthwash and tablet for pain reduction.
We hypothesize that diclofenacsodium local application (0.074% mouthwash) will have equal analgesic effect ascompared to its systemic administration (tablet), but it would be better interms of its anti-inflammatory effect and patient’s acceptability when usedafter periodontal flap surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having periodontal pocket depth ranging from 5mm to 8mm.
- •2.Patients indicated for periodontal surgery bilaterally in same arch.
- •3.Systemically healthy patients.
排除标准
- •1.Patients having endo-perio lesions.
- •2.Patients requiring resective osseous surgery or regenerative osseous surgery.
- •3.Patients with the history of intolerance or hypersensitivity to diclofenac.
- •4.Any systemic diseases or condition that affects the oral tissues, 5.Pregnant or lactating women.
- •6.Acute gingival or periodontal disease.
- •7.Patients on oral/systemic NSAIDs therapy for the last three months.
结局指标
主要结局
Diclofenac sodium local application (0.074% mouthwash) will have equal analgesic effect as compared to its systemic administration (tablet), but it would be better in terms of its anti-inflammatory effect and patient’s acceptability when used after periodontal flap surgery.
时间窗: Analgesic effect will checked on 1st 2nd 3rd and 4th day after surgery. Inflammation will be assessed after 7 days 1 month and 3 months after surgery.
次要结局
未报告次要终点