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临床试验/NCT07171879
NCT07171879已完成不适用

Partial Extraction Therapy for Facial Contour Preservation, "Old is Gold or Time for Change?" A Randomized Clinical Trial

Soaad Tolba Mohammed Tolba Badawi2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Alveolar Ridge Width Change

研究概览

简要总结

This study is testing new methods to preserve the jawbone and gum tissue after removing a damaged front tooth. Normally, when a tooth is taken out, the bone and gums in that area shrink, which can make future dental treatment more difficult and affect appearance. A technique called Partial Extraction Therapy (Pontic Shield Technique) keeps part of the tooth root in place to help maintain the natural shape of the bone and gums. Another method, called Mineralized Plasmatic Matrix (MPM), uses a patient's own blood mixed with bone particles to support healing.

In this randomized clinical trial, 56 patients were assigned to one of four groups:

Group I: Tooth extraction only Group II: Tooth extraction with MPM grafting Group III: Pontic shield technique alone Group IV: Pontic shield technique with MPM grafting The main outcome measured was the amount of bone width preserved, using 3D X-rays (CBCT). Other outcomes included bone height and soft-tissue healing over 4 months.

This research will help determine whether the pontic shield technique, with or without MPM, provides better preservation of bone and gum tissue compared to tooth extraction alone.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥18 years).
  • Classified as ASA I (healthy) according to the American Society of Anesthesiologists Physical Status Classification.
  • Presence of Type 1 extraction sockets (intact buccal bone and soft tissues).
  • Adequate oral hygiene.
  • Sufficient inter-arch space for prosthetic rehabilitation.
  • Willingness to comply with study protocol and follow-up schedule.

排除标准

  • Systemic conditions affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis, immunosuppression).
  • History of head and neck radiotherapy or bisphosphonate therapy.
  • Acute infection or suppuration at the extraction site.
  • Severe periodontal disease.
  • Root caries or tooth mobility.
  • Buccal bone plate loss due to vertical/horizontal root fractures or advanced periodontitis.

结局指标

主要结局

Alveolar Ridge Width Change

时间窗: Baseline (pre- or immediate post-extraction) to 4 months.

Mean changes in alveolar ridge width measured at standardized reference points on cone-beam computed tomography (CBCT) Unit of Measure: millimeters (mm)

次要结局

  • Buccal and Palatal Bone Height Change(Baseline to 4 months.)
  • Soft-Tissue Healing (Wound Healing Index, WHI)(1 week and 4 months post-extraction.)

研究者

发起方
Soaad Tolba Mohammed Tolba Badawi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Soaad Tolba Mohammed Tolba Badawi

Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University

Mansoura University

研究点 (2)

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