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临床试验/NCT05001919
NCT05001919已完成1 期

Concentrated Growth Factors Membrane in the Treatment of Intrabony Periodontal Defects in Localized Aggressive Periodontitis. A Randomized Controlled Split-Mouth Clinical Study

Tanta University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

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

Placebo Comparator

10 sites treated with surgery and bone graft and collagen membrane as GTR

干预措施: GTR (Procedure)

Concentrated growth factor membrane

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

malak mohamed shoukheba

associate prof

Tanta University

研究点 (1)

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