Evaluation of Locally Delivered Propolis Gel As an Adjunct to Nonsurgical Periodontal Therapy in the Management of Periodontitis: a Randomized Controlled Clinical Study with Biochemical Assessment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Regarding clinical periodontal parameters as a primary objective.
研究概览
简要总结
Assess the efficacy of locally delivered propolis gel as an adjunct to scaling and root planning in management of Stage II, Grade B periodontitis
. Subjects and Methods
I. Patients' selection:
Thirty-two (32) patients were recruited from the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University.
This study was designed as a randomized, controlled, 2-parallel arm, triple blinded, single center clinical trial.
Thirty-two eligible patients with stage II and Grade B periodontitis were randomly assigned into 2 groups:
- Group 1 (intervention group) was treated with SRP combined with intrasulcular application of 1% Propolis gel.
- Group 2 (control group) was treated with SRP combined with intrasulcular application of placebo gel.
详细描述
Thirty-two eligible patients with stage II and Grade B periodontitis were randomly assigned into 2 groups:
- Group 1 (intervention group) was treated with SRP combined with intrasulcular application of 1% Propolis gel.
- Group 2 (control group) was treated with SRP combined with intrasulcular application of placebo gel.
Eligibility criteria:
The patients were recruited according to the following criteria:
Inclusion criteria
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1-Both genders aged from 30-50 years 2- Systemically healthy patients as evidenced by (modified Cornell medical index) (Pendleton et al., 2004).
- •3- Patients with Stage II, Grade B Periodontitis, Test sites at least 2 sites have Propping depth (PD)= 4-5 mm or Clinical attachment loss (CAL)= 3-4mm.
- •4- Patient with no history of periodontal therapy or use of antibiotics or anti-inflammatory in the preceding 6 months.
- •5- Patient willing to comply with oral hygiene instructions
排除标准
- •1-Patients with known allergy to propolis. 2- Smokers or Alcoholics patients. 3- Pregnant and lactating females.
研究组 & 干预措施
SRP
The participants were randomly assigned to receive medicated with SRP combined with intrasulcular application of placebo gel. After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing).
干预措施: Control (placebo) group (Drug)
PROPOLIS group
After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort.
2- Oral Hygiene Instructions Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing).
3-Base line visit (Local delivery application): Propolis gel will be applied by syringe with blunt tip gently and removed slowly in order not to harm the tissue for group 1 patients (Test group) after phase 1 therapy at the second day (48 hours) following non-surgical periodontal therapy
干预措施: Study Group (Drug)
结局指标
主要结局
Regarding clinical periodontal parameters as a primary objective.
时间窗: The following clinical parameters will be recorded for the individuals preoperatively and 3 and 6 months postoperatively.
Probing pocket depth will be measured from the gingival margin to the base of the periodontal pocket to the nearest mm. with use of periodontal probe.
次要结局
- B) Secondary outcome: • Biochemically By analyzing quantitative changes the level of prostaglandin E2 (PGE2) in the gingival crevicular fluid (GCF)(The examined area will be dried by gentle air stream and isolated with cotton rolls to prevent contamination with saliva. Next, with sterile tweezers one perio paper will be inserted into the selected pocket and left in situ for 30 seconds. Perio paper a)
研究者
Huda Mohamed
BDS, Clinical demonstrator, oral medicine and periodontology
Horus University