Evaluation of Injectable PRF With Vitamin D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- pocket depth reduction
研究概览
简要总结
a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients
详细描述
in this clinical trial, the treatment of periodontal pockets in stage III periodontitis patients will be evaluated. the study participants will be divided in 3 groups:
First group >> will be treated with professional mechanical plaque removal (PMPR) only.
second group >> will be treated with PMPR + locally applied iPRF.
Third group >> will be treated with PMPR + locally applied iPRF + vitamin D.
Then the results will be compared after 6 months of the treatment (clinically and radiographically).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
the masking will be applied in the two test groups where iPRF will be used and neither the principle investigator nor the participants will know if vitamin D will be applied to the iPrf or a placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with healthy systemic condition.
- •Adult patients ˃ 18 years old.
- •Patients with Stage III periodontitis.
- •Patients accept 3-month follow-up period (cooperative patients).
- •Patients provide an informed consent.
排除标准
- •Presence of prosthetic crowns.
- •Extensive interproximal restorations.
- •Periodontal therapy within the last 12 months.
- •Having undergone surgical periodontal therapy or undergoing orthodontic treatment.
- •Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- •The use of antibiotics or anti-inflammatory drugs 3-month prior to the procedure and till the end of 6-month of follow-up.
- •Pregnant females.
研究组 & 干预措施
PMPR only
scaling and root planing only will be made for group 1 (control group)
干预措施: PMPR only (Procedure)
PMPR + iPRF
scaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1.
干预措施: PMPR+iPRF (Procedure)
PMPR + iPRF + Vit.D
scaling and root planing plus locally applied iPRF and vitamin D in the periodontal pocket will be made for test group 2.
vitamin D will be obtained from a commercial product in the Egyptian pharmacies called (Devarol S) in the form of injectable ampoules containing 200000 IU of cholecalciferol (2.5 mg/ml)
干预措施: PMPR+iPRF+Vit.D (Drug)
结局指标
主要结局
pocket depth reduction
时间窗: 6 months
estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment
次要结局
- clinical attachment level (CAL) gain(6 months)
- Plaque index(6 months)
- Gingival Marginal Level (GML)(6 months)
- Post-operative Pain(6 months)
- Treatment time taken for each groups(6 months)
- degree of bone fill or loss(6 months)
- Bleeding on probing (BOP)(6 months)
研究者
Ahmed hamed fattouh hamed
dentist
Cairo University