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| Name | Class |
|---|---|
| LifeNet Health | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Other | Observational study; alveolar ridge preservation |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Parameters | bone width | Measured before surgery, during surgery and at 4 months |
| Clinical Parameters | bone height | Measured before surgery, during surgery and at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic Parameters | RNA transcriptomic analysis | Bone samples harvested at 4 months |
| Histological Parameters | Histological analysis of bone cores: %mineralized bone |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Parameters | gingival width | Measured at baseline (before surgery) |
| Clinical Parameters | gingival thickness | Measured at baseline (before surgery) |
Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vrisiis Kofina, DDS, MS | Contact | 516-817-0393 | vrisiis.kofina@marquette.edu | |
| McKenna Schnack, DDS, MS | Contact | 515-822-3552 | mckenna.schnack@marquette.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vrisiis Kofina, DDS, MS | Marquette University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marquette University School of Dentistry Graduate Periodontics Clinic | Milwaukee | Wisconsin | 53233 | United States |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Bone cores will be harvested at the time of implant placement using trephine drills via surgical guides.
| Samples harvested at 4 months |
| Histological Parameters | Histological analysis of bone cores: %osteoid | Samples harvested at 4 months |
| Histological Parameters | Histological analysis of bone cores: %residual bone graft | Samples harvested at 4 months |
| Histological Parameters | Histological analysis of bone cores: %soft tissue | Samples harvested at 4 months |
| Histological Parameters | Histological analysis of bone cores: numbers of osteoblasts and osteoclasts | Samples harvested at 4 months |
| Micro-CT Parameters | Histological analysis of bone cores: bone mineral density | Samples harvested at 4 months |
| Micro-CT Parameters | Histological analysis of bone cores: tissue mineral density | Samples harvested at 4 months |
| Micro-CT Parameters | Histological analysis of bone cores: bone volume / tissue volume (BV/TV) | Samples harvested at 4 months |
| Micro-CT Parameters | Histological analysis of bone cores: trabecular number | Samples harvested at 4 months |
| Micro-CT Parameters | Histological analysis of bone cores: trabecular separation | Samples harvested at 4 months |
| Micro-CT Parameters | Histological analysis of bone cores: trabecular thickness | Samples harvested at 4 months |
| Patient-reported Parameters | Oral Health Impact Profile -14 (OHIP-14). Range from 0 (no impact) to 56 (most severe impact). | Measured before surgery, at 1, 2 and 6 weeks, and 4 months |
| Patient-reported Parameters | VAS for pain (0-100). Zero indicates no pain and 100 the worst pain imaginable. | Measured before surgery and at 1, 2 and 6 weeks, and 4 months |
| Patient-reported Parameters | VAS for swelling (0-100). Zero indicates no swelling and 100 the worst swelling imaginable. | Measured before surgery and at 1, 2 and 6 weeks, and 4 months |
| Patient-reported Parameters | VAS for difficulty of mouth opening (0-100). Zero indicates no difficulty of mouth opening and 100 complete inability to open mouth. | Measured before surgery, at 1, 2 and 6 weeks, and 4 months |
| Clinical Parameters | wound opening | Measured immediately after surgery, at 1, 2 and 6 weeks and 4 months |
| Clinical Parameters | bleeding | Measured at 1, 2 and 6 weeks and 4 months |
| Clinical Parameters | grafting material discharge | Measured at 1, 2 and 6 weeks and 4 months |
| Clinical Parameters | flap necrosis | Measured at 1, 2 and 6 weeks and 4 months |