Wound Healing Following Extraction and Ridge Preservation in Smokers and Non-smokers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study.
- Who it may be relevant to
- Registry conditions: Smoking, Cigarette, Alveolar Bone Grafting, Wound Healing, Bone Healing. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other observational study
Observational study; alveolar ridge preservation
Primary outcome measures
- Clinical Parameters [Time frame: Measured before surgery, during surgery and at 4 months]
- Clinical Parameters [Time frame: Measured before surgery, during surgery and at 4 months]
Secondary outcome measures (12)
- Genetic Parameters [Time frame: Bone samples harvested at 4 months]
- Histological Parameters [Time frame: Samples harvested at 4 months]
- Histological Parameters [Time frame: Samples harvested at 4 months]
- Histological Parameters [Time frame: Samples harvested at 4 months]
- Histological Parameters [Time frame: Samples harvested at 4 months]
- Histological Parameters [Time frame: Samples harvested at 4 months]
- Micro-CT Parameters [Time frame: Samples harvested at 4 months]
- Micro-CT Parameters [Time frame: Samples harvested at 4 months]
- Micro-CT Parameters [Time frame: Samples harvested at 4 months]
- Micro-CT Parameters [Time frame: Samples harvested at 4 months]
- Micro-CT Parameters [Time frame: Samples harvested at 4 months]
- Micro-CT Parameters [Time frame: Samples harvested at 4 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Uncontrolled periodontal disease
- Uncontrolled systemic disease
- Pregnancy
- Use of therapy and/or medication that impairs wound healing (e.g., bisphosphonates, steroids, chemotherapy, radiotherapy etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Marquette University School of Dentistry Graduate Periodontics Clinic — Milwaukee
Identifiers
NCT: NCT07372183 · HR-4728