Smoking, CigaretteNCT07372183
Wound Healing Following Extraction and Ridge Preservation in Smokers and Non-smokers
An observational study of Smoking, Cigarette and Alveolar Bone Grafting, run by Marquette University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette, Alveolar Bone Grafting, Wound Healing
- What is being tested?
- observational study
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.
Who may be able to join
- 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
Who cannot join
- Uncontrolled periodontal disease
- Uncontrolled systemic disease
- Pregnancy
- Use of therapy and/or medication that impairs wound healing (e.g., bisphosphonates, steroids, chemotherapy, radiotherapy etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Marquette University School of Dentistry Graduate Periodontics Clinic
Milwaukee, Wisconsin, 53233
Vrisiis Kofina, DDS, MS, 4142886521, vrisiis.kofina@marquette.edu
Arndt Guentsch, DMD, PhD, MHBA, MS, 4142886089, arndt.guentsch@marquette.edu
About this study
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.
Read the 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.
- Conditions
- Smoking, Cigarette, Alveolar Bone Grafting, Wound Healing, Bone Healing, Tooth Extraction Site Healing
- Being tested
- observational study
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Observational study; alveolar ridge preservation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: observational study | |
| 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. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Parameters
bone width
Measured: Measured before surgery, during surgery and at 4 months
Clinical Parameters
bone height
Measured: Measured before surgery, during surgery and at 4 months
Secondary outcomes (16)
Genetic Parameters
RNA transcriptomic analysis
Measured: Bone samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %mineralized bone
Measured: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %osteoid
Measured: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %residual bone graft
Measured: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: %soft tissue
Measured: Samples harvested at 4 months
Histological Parameters
Histological analysis of bone cores: numbers of osteoblasts and osteoclasts
Measured: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: bone mineral density
Measured: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: tissue mineral density
Measured: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: bone volume / tissue volume (BV/TV)
Measured: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: trabecular number
Measured: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: trabecular separation
Measured: Samples harvested at 4 months
Micro-CT Parameters
Histological analysis of bone cores: trabecular thickness
Measured: 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: 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: 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: 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: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health
- Responsible party
- Principal investigator, Vrisiis Kofina, Marquette University
- Investigators
- Vrisiis Kofina, DDS, MS, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372183
- Sponsor's protocol ID
- HR-4728
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Following Extraction and Ridge Preservation in Smokers and Non-smokers
- ClinicalTrials.gov ID
- NCT07372183
- Acronym / sponsor ID
- HR-4728
- Conditions
- Smoking, Cigarette, Alveolar Bone Grafting, Wound Healing, Bone Healing, Tooth Extraction Site Healing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- LifeNet Health
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Other: observational studySubjects 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 | – | Other: observational studySubjects qualify as nonsmokers if they have never smoked and upon confirmation by the smokerlyzer test of carbon monoxide concentation of less than 8ppm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Uncontrolled periodontal disease
- Uncontrolled systemic disease
- Pregnancy
- Use of therapy and/or medication that impairs wound healing (e.g., bisphosphonates, steroids, chemotherapy, radiotherapy etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyObservational study; alveolar ridge preservation | Other | Non-smokers, Smokers |
Primary outcome
Clinical Parameters
Time frame: Measured before surgery, during surgery and at 4 months
bone width
Clinical Parameters
Time frame: Measured before surgery, during surgery and at 4 months
bone height
16 secondary outcomes
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
Patient-reported Parameters
Time frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
Patient-reported Parameters
Time frame: Measured before surgery and at 1, 2 and 6 weeks, and 4 months
Patient-reported Parameters
Time frame: Measured before surgery and at 1, 2 and 6 weeks, and 4 months
Patient-reported Parameters
Time frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vrisiis Kofina, DDS, MS principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, Cigarette and Alveolar Bone Grafting, run by Marquette University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vrisiis Kofina, DDS, MS (516-817-0393, vrisiis.kofina@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Parameters (time frame: Measured before surgery, during surgery and at 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.