Concentrated Growth Factors Membrane in the Treatment of Intrabony Periodontal Defects in Localized Aggressive Periodontitis. A Randomized Controlled Split-Mouth Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- probing pocket depth
研究概览
简要总结
A total of 20 intra-bony defects in 10 LAP patients were randomly assigned into two groups 10 defects each in a split-mouth design. Group I treated by surgery plus Bio-Oss bone graft + collagen membrane (Control group). Group II, treated by surgery plus Bio-Oss bone graft + CGF membrane (Test group). Gingival index (GI), bleeding on probing (BOP), probing pocket depth and clinical attachment level (CAL) were assessed at baseline, 3, 6, and 12 months. Cone beam radiograph evaluation was taken at baseline, and 12 months after surgery..
详细描述
Full mouth scaling and root planing was done for all patients followed by Augmentin I gm and metronidazole 500 mg twice daily for 7 days. Additionally, Comprehensive oral hygiene instructions were given to the patients.
Sites grouping Four weeks following phase I therapy, the twenty defect sites were randomly classified by sealed envelopes into two groups ten each by a masked supervisor as follows: Group I (10 sites) received surgery + Bio-oss bone graft (Geistlich Pharma AG, Wolhusen, Switzerland) + collagen membrane (control group). Group II (10 sites) received surgery + Bio-oss bone graft +concentrated growth factors membrane (tested group).
After the administration of local anesthesia (Xylocaine 2% Adrenaline 1:80,000, ICPA, India), buccal and lingual sulcular incisions were made, and mucoperiosteal flaps were elevated. Thorough debridement of the defects was achieved with hand instruments. The surgical area was irrigated with copious amounts of sterile saline. Bio-oss granules were placed into the defects and the CGFs membrane was trimmed and adapted over the entire defect to cover 2-3 mm of the surrounding alveolar bone and to ensure the stability of the wound and the graft material. For control sites, Bio-oss grafts and a bioresorbable collagen membrane were trimmed and adjusted over the defect in such a way that the whole defect and 2-3 mm of the surrounding alveolar bone were completely covered. Then the flap was repositioned to achieve complete interproximal closure. The flap was then sutured with 4-0 absorbable sutures with single interrupted sutures. A periodontal pack was applied over the surgical area for 10 days.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Investigator Malak. Shoukheba screened the patients and randomly assigned them to test and control groups and performed the treatment procedures for all participants. Investigator Ahmed. Bader recorded the clinical parameters and she was masked to the randomization for the extent of the study.
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of angular periodontal intra-bony defects with clinical attachment loss ≥5 mm measured from CEJ to the deepest propping depth with no evidence of gingival recession
- •optimal compliance as evidenced by no missed treatment appointment and high attitude towards oral hygiene
排除标准
- •Patients with relevant medical conditions that may affect periodontal regeneration and surgery
- •smokers, pregnant or lactating women
- •those whom periodontal surgery had previously been carried out on the selected site,
- •and patients who taking any drug known to affect the number or function of platelets
研究组 & 干预措施
collagen membrane
10 sites treated with surgery and bone graft and collagen membrane as GTR
干预措施: GTR (Procedure)
Concentrated growth factor membrane
10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR
干预措施: concentrated growth factor (Procedure)
结局指标
主要结局
probing pocket depth
时间窗: 12 months
measured from the gingival margin to the base of the pocket using periodontal probe in mm
clinical attachment level
时间窗: 12months
measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm
radiographic defect area by cone beam x ray
时间窗: 12 months
measured in square millimeter from cone beam x ray
radiographic bone density by cone beam
时间窗: 12 months
By Hounsfield unit from the cone beam x ray
次要结局
- bleeding on probing(12 months)
- gingival index(12 months)
研究者
malak mohamed shoukheba
associate prof
Tanta University
