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临床试验/NCT06318247
NCT06318247Unknown不适用

Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets in the Distal of the Mandibular Second Molar After the Extraction of the Third Molar

The Dental Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Probing pocket depths (PPD)

研究概览

简要总结

To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars.

详细描述

The mandibular third molar is the last tooth to erupt in the dentition, and due to the insufficient eruption position, it can lead to different degrees of impact. During the eruption of impacted tooth, the crown may be partially or completely covered by the gingival flap. A deep blind pocket is formed between the gingival flap and the tooth crown, and food and bacteria are easily impinged in the blind pocket. Under the influence of oral environment and dental plaque, the presence of blind pockets can lead to the loss of periodontal attachment and the absorption of alveolar bone, thus affecting the distal periodontal status of adjacent molars.

Organic bone xenograft material composed of absorbable organic bovine hydroxyapatite is one of the commonly used transplantation materials for repairing bone defects. The application effect of allogeneic bone materials in periodontal therapy has been recognized by many experts and scholars. Guided bone regeneration (GBR), as a conventional periodontal bone graft, has achieved good results in periodontal tissue regeneration. Aljuboori et al. found that when the third molar was removed and GBR was performed at the same time, the depth of distal periodontal pocket probing of the adjacent second molar was significantly reduced in the re-examination 6 months after surgery.

Hence, this study intends to use xenograft combined with barrier membrane to improve the formation of distal periodontal pocket of the second molars after third molars extraction.

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)

入排标准

年龄范围
26 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 26-45 years old
  • Completely or partially impacted mandibular third molar
  • No evidence of acute inflammation
  • In good physical status and oral health
  • Regular attendance at control visits

排除标准

  • pregnancy or lactation
  • Aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others
  • Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism
  • Patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders
  • Heavy smoke (10 cigarettes/day or more)
  • The second molar has no contact with the third molar, or the third molar crown has alveolar bone

研究组 & 干预措施

Control group

Sham Comparator

Tooth extraction of third molars

干预措施: site preservation (Procedure)

GBR group

Experimental

Tooth extraction of third molars with site preservation using bio-oss (0.5g, Small granule) and bio-guide (25*25mm size). The bone graft material used in the surgical procedure was provided by Geistlich Pharma AG.

干预措施: site preservation (Procedure)

结局指标

主要结局

Probing pocket depths (PPD)

时间窗: postoperative 14 days, 3 6 and 12 months

The depth of the periodontal pocket is examined with a periodontal probe. Probing pocket depths (PPD) measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML) in postoperative 14days, 3, 6 and 12 months. The distal measurements are the primary outcomes. The higher the value, the worse the periodontal condition.

Clinical attachment lose (CAL)

时间窗: postoperative 14 days, 3 6 and 12 months

clinical attachment lose (CAL) were measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML). The distal measurements are the primary outcomes.

Bleeding on probing (BOP)

时间窗: postoperative 14 days, 3 6 and 12 months

Periodontal probing for bleeding can determine whether the gingiva is in a state of inflammation or whether periodontal disease is in an active phase.

Distal bone wall defect (DBWD)

时间窗: postoperative 14 days, 3 6 and 12 months

The height of distal bone wall defect of the second mandibular molar is measured by cone-beam CT.

次要结局

  • Pain score(pre-operation, postoperative 14 days, 3 6 and 12 months)
  • Patient satisfaction(pre-operation, postoperative 14 days, 3 6 and 12 months)
  • Gingival index (GI)(pre-operation, postoperative 14 days, 3 6 and 12 months)

研究者

发起方
The Dental Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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