Clinical and Laboratory Evaluation of Placenta Extract Gel as an Adjunct to Non Surgical Periodontal Therapy in Patients With Grade B Stage II Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- probing pocket depth (PD)
研究概览
简要总结
Introduction: Periodontal disease is one of the most prevalent global chronic disorders. Pathology affecting the structure surrounding teeth results in inflammation initiated by bacterial aggregation and alteration in their profile.
conventional periodontal therapeutics has focused on the control of etiologic agents, thereby promoting healing, repair of tissues delivery of therapeutic agents into the pocket act as drug reservoirs which could alter pathogenic flora and promote its repair and wound healing. Aim of the study: Evaluate the effect of locally delivered placenta extract gel as an adjunct to scaling and root planning in the treatment of periodontal pocket. Methodology: 30 patients with grade B stage II periodontitis will be selected from the Faculty of Dentistry Suez Canal University outpatient clinic and divided into 2 equal groups. Group I: will have scaling and root planning.
Group II: will have scaling and root planning with placenta extract gel locally delivered in the periodontal pocket. All clinical parameters (plaque index, gingival index, probing pocket depth, and clinical attachment) and lab investigations (vascular endothelial growth factor and fibroblast growth factor) will be measured at 0,1 and 3 months. All results will be tabulated and statistically analyzed using the SPSS program.
详细描述
Group I: (control group): where subgingival scaling and root planning will be performed and the pocket will be allowed to heal with secondary intention. Group II (test group): where subgingival scaling and root planing, and 1ml of human placental extracts gel* adsorbed in 30 beads of gelatin foam of 1sq. mm, will be placed into the pockets with the help of a probe to fill the sulcus to the deepest point & coepak will be placed. patients will be recalled after seven 12 days to remove the coePak. A customized acrylic stent will be fabricated for each patient to provide a reproducible insertion axis for the periodontal probe. The stent will be grooved in an occlusal-apical direction for the above-mentioned purpose.
Lab assessment:
The area will be isolated with cotton rolls, gingival crevicular fluid will be collected using a paper point three times for each pocket, and samples will be stored at -80°.
Vascular endothelial growth factor and fibroblast growth factor will be measured for the two groups using the ELISA technique.
Clinical assessment:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having a pocket of 4-5 mm ( grade B stage II periodontitis).
排除标准
- •patients with known systemic conditions like Diabetes mellitus, hypertension, atherosclerosis, and other conditions known to affect periodontal status adversely.
- •patients suffering from stage III grade C periodontitis.
- •pregnant and lactating women,
- •known harmful habits like alcohol consumption, and tobacco.
- •any form of periodontal therapy during the last six months & antimicrobial therapy during the last 3 months.
研究组 & 干预措施
scaling and root planning+planenta extract gel group
干预措施: Placental Extract (Drug)
结局指标
主要结局
probing pocket depth (PD)
时间窗: 3 months
Measured from the free gingival margin to the bottom of the pocket with an unc 15 periodontal probe
gingival index (GI)
时间窗: 3 months
o determine the gingival index of the patients, gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of all teeth was evaluated. The gingival index of an individual was obtained by summing the values determined for each tooth and calculating the averages. To determine the gingival index, Löe \& Silness reference values were taken as a basis: Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous, and ulcerated gingiva. There is spontaneous bleeding.
plaque index (PI)
时间窗: 3 months
PI was used to determine the amount of plaque on the tooth surface To determine the plaque index, Silness \& Löe reference values were taken as a basis: Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
clinical attachment level(CAL).
时间窗: 3 months
The distance from CEJ to the bottom of the pocket. It was measured in the same way described for probing depth. CAL was recorded by subtracting the length of the deepest probing depth from the stent by the length from the stent to the cemento-enamel junction.
次要结局
- Vascular endothelial growth factor (VEGF)(3 months)
- fibroblast growth factor (FGF)(3 months)
研究者
Aya mohamed ahmed awad
dr
Suez Canal University