Efficacy of Curcumin Gel as an Adjunct to Scaling and Root Planing on Salivary Procalcitonin Level in the Treatment of Periodontitis Patients: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Probing pocket depth reduction
研究概览
简要总结
Objectives: To evaluate the efficacy of curcumin gel as an adjunct to scaling and root planing (SRP) on the salivary procalcitonin level in the treatment of periodontitis.
Materials and methods: seventy patients (n=70) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, sixteen patients (n=16) were excluded as eight patients (n=8) weren't met the inclusion criteria, and other eight patients were divided into (n= 4) declined to participate with (n=4) were excluded due to pregnancy and lactation. The participants fifty -four patients were classified into three groups: group I (healthy individuals), group II (SRP group), and group III (curcumin gel group). Patients in groups II and III included stage II grade A periodontitis. Patients in group II were treated with SRP only while in group III curcumin gel was applied weekly for four weeks after SRP had been completed. Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)) and saliva samples for procalcitonin (PCT) assessment using an enzyme-linked immunosorbent assay (ELISA) test were collected and measured at baseline and again after six weeks.
详细描述
Study population The randomized controlled clinical trial included fifty-four participants selected from the Department of Oral Medicine and Periodontology Outpatient Clinic, Faculty of Dentistry, Mansoura University from January 2021 to May 2021. Thirty-six patients with periodontitis (stage II grade A) and eighteen healthy volunteers (negative control group) participated in the study.
A. Inclusion criteria for patient selection: The selected patients included:
- Participants of both sexes between the ages of thirty to fifty -five years old
- Participants with periodontitis (stage II grade A with PD of 3-5 mm and CAL of 3-4mm).
B. Exclusion criteria included:
- Participants with known systemic diseases
- Pregnant and lactating participants.
- Tobacco (smoking/chewing).
- History of antibiotic and periodontal therapy in the last 3 months.
- Participants who weren't compliant with oral hygiene procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The patients with periodontitis groups were randomly selected into either group II or III using the coin toss method. Hence the study groups were classified into three groups as follows, group I (negative control group): eighteen subjects with clinically healthy gingiva were selected to participate in the study as a reference group, and group II (positive control group): eighteen patients with periodontitis (stage II grade A) were selected and treated with non-surgical periodontal therapy (SRP) only, and group III (study group): eighteen patients with periodontitis (stage II grade A) were selected and treated with SRP followed by curcumin gel application
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inclusion criteria were participants of both sexes, between the ages of thirty and fifty -five years old with periodontitis (stage II grade A).
排除标准
- •exclusion criteria involved participants with known systemic diseases, pregnant and lactating patients, tobacco users (smoking /chewing), history of antibiotic and periodontal therapy in the last three months, and participants who weren't compliant with oral hygiene procedures.
研究组 & 干预措施
Study group
Study group treated with curcumin gel
干预措施: Local drug delivery (Other)
Study group
Study group treated with curcumin gel
干预措施: curcumin gel (Drug)
结局指标
主要结局
Probing pocket depth reduction
时间窗: Six weeks
Clinical attachment level gain
次要结局
未报告次要终点
研究者
Reham abdelfatah
BDS, Clinical demonstrator, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,
Mansoura University