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临床试验/NCT07372183
NCT07372183尚未招募不适用

Wound Healing Following Extraction and Ridge Preservation in Smokers and Non-smokers

Marquette University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年1月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
1
主要终点
Clinical Parameters

研究概览

简要总结

The goal of this study is to evaluate bone wound healing following extraction and alveolar ridge preservation (bone graft and membrane) clinically, histologically and in relation to gene expression in smokers and non-smokers. Data from a small group of participants will be analyzed after age-matched subjects undergo extraction and alveolar ridge preservation prior to implant placement. The data obtained in this pilot study will be used to plan a full-fledged study involving a larger number of smoking and non-smoking participants to compare the two groups.

详细描述

All research procedures will start after IRB approval. Patients of the Graduate Periodontics Clinic in need of extraction, bone graft and membrane will be recruited. There will be two groups (smokers and non-smokers) and their demographic and social, periodontal, surgery-related, anatomical and healing variables as well as patient-reported outcomes will be recorded at different time points (immediately before, during and immediately after surgery and 1, 2, 6 weeks and 4 months) in order to evaluate wound healing outcomes and differences between the groups. The demographic and social variables evaluated are age, gender, race, medical history, medications, smoking (via interview and breath test-smokerlyzer) and alcohol consumption (via interview). The periodontal variables are tooth mobility, probing depth, attachment level, gingival and plaque index. The surgery-related variables include intraoperative complications, duration of procedure, anesthetic amount, type and approach and operator experience. The anatomical variables are bone height and width (buccolingual and buccal dimension), bone density (in Cone Beam Computed Tomographies - CBCTs) and gingival width and thickness. The healing variables include wound opening (tested clinically and in photos), bleeding, grafting material discharge, flap necrosis, loose sutures, and temporary restoration adjustment. The patient-reported outcomes are Oral Health Impact Questionnaire-14 (OHIP-14), Visual Analogue Scale (VAS) for pain, swelling and difficulty of mouth opening. At 4 months during the implant placement appointment, a bone core will be harvested via a 3D printed surgical guide based on virtual CBCT planning. The core willl be used of microCT and histological analysis as well as total RNA extraction and RNA sequencing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (18-75 years)
  • Good general health (controlled conditions)
  • Smokers (≥10 cigarettes/day for ≥5 years) and never smokers. Confirmation of smoking status will be done via use of a smokerlyzer. The cut-off point for distinguishing smokers from non-smokers is 8 carbon monoxide parts per million (ppm).
  • Periodontal status: periodontal health, gingivitis on intact or reduced periodontium, treated periodontitis
  • Intact post-extraction bony walls or less than 50% bone dehiscence
  • Distance at least 8 mm of vertical bone height between bone crest and anatomical structures (i.e. sinus floor, inferior alveolar nerve (IAN) canal, mental foramen)
  • Extracted tooth root in the same three-dimensional position as the future implant placement so that the bone core biopsy can be taken from a site totally within the confines of the former tooth socket without inclusion of surrounding native alveolar bone
  • Scheduled for single tooth extraction with bone graft placement and membrane

排除标准

  • Uncontrolled periodontal disease
  • Uncontrolled systemic disease
  • Pregnancy
  • Use of therapy and/or medication that impairs wound healing (e.g., bisphosphonates, steroids, chemotherapy, radiotherapy etc.)

研究组 & 干预措施

Smokers

Subjects are qualified as smokers if they report smoking ≥10 cigarettes/day for ≥5 years, and maintain a 8ppm carbon monoxide concentration or higher via smokerlyzer test.

干预措施: observational study (Other)

Non-smokers

Subjects qualify as nonsmokers if they have never smoked and upon confirmation by the smokerlyzer test of carbon monoxide concentation of less than 8ppm.

干预措施: observational study (Other)

结局指标

主要结局

Clinical Parameters

时间窗: Measured before surgery, during surgery and at 4 months

bone width

次要结局

  • Genetic Parameters(Bone samples harvested at 4 months)
  • Histological Parameters(Samples harvested at 4 months)
  • Micro-CT Parameters(Samples harvested at 4 months)
  • Patient-reported Parameters(Measured before surgery, at 1, 2 and 6 weeks, and 4 months)
  • Patient-reported Parameters(Measured before surgery and at 1, 2 and 6 weeks, and 4 months)

研究者

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

Vrisiis Kofina

Director, Advanced Education in Periodontics Program, Assistant Professor of Periodontics

Marquette University

研究点 (1)

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