An observational study in Smoking, Cigarette, Alveolar Bone Grafting and Wound Healing, sponsored by Marquette University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Marquette University · Observational
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.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 12 is below the median of 120 across 57 observational studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Marquette University is the lead sponsor of 38 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: observational study
Subjects qualify as nonsmokers if they have never smoked and upon confirmation by the smokerlyzer test of carbon monoxide concentation of less than 8ppm.
Other: observational study
Observational study; alveolar ridge preservation
Clinical Parameters
bone width
Time frame: Measured before surgery, during surgery and at 4 months
Clinical Parameters
bone height
Time frame: Measured before surgery, during surgery and at 4 months
Genetic Parameters
RNA transcriptomic analysis
Time frame: Bone samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %mineralized bone
Time frame: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %osteoid
Time frame: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %residual bone graft
Time frame: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %soft tissue
Time frame: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: numbers of osteoblasts and osteoclasts
Time frame: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: bone mineral density
Time frame: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: tissue mineral density
Time frame: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: bone volume / tissue volume (BV/TV)
Time frame: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: trabecular number
Time frame: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: trabecular separation
Time frame: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: trabecular thickness
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
Clinical Parameters
gingival width
Time frame: Measured at baseline (before surgery)
Clinical Parameters
gingival thickness
Time frame: Measured at baseline (before surgery)
Clinical Parameters
wound opening
Time frame: Measured immediately after surgery, at 1, 2 and 6 weeks and 4 months
Clinical Parameters
bleeding
Time frame: Measured at 1, 2 and 6 weeks and 4 months
Clinical Parameters
grafting material discharge
Time frame: Measured at 1, 2 and 6 weeks and 4 months
Clinical Parameters
flap necrosis
Time frame: Measured at 1, 2 and 6 weeks and 4 months
Plan to share: No
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