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

January 20, 2026 updated by: Vrisiis Kofina, Marquette University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Marquette University School of Dentistry Graduate Periodontics Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vrisiis Kofina, DDS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: observational study
Observational study; alveolar ridge preservation
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.
Other: observational study
Observational study; alveolar ridge preservation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Parameters
Time Frame: Measured before surgery, during surgery and at 4 months
bone width
Measured before surgery, during surgery and at 4 months
Clinical Parameters
Time Frame: Measured before surgery, during surgery and at 4 months
bone height
Measured before surgery, during surgery and at 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genetic Parameters
Time Frame: Bone samples harvested at 4 months
RNA transcriptomic analysis
Bone samples harvested at 4 months
Histological Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: %mineralized bone
Samples harvested at 4 months
Histological Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: %osteoid
Samples harvested at 4 months
Histological Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: %residual bone graft
Samples harvested at 4 months
Histological Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: %soft tissue
Samples harvested at 4 months
Histological Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: numbers of osteoblasts and osteoclasts
Samples harvested at 4 months
Micro-CT Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: bone mineral density
Samples harvested at 4 months
Micro-CT Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: tissue mineral density
Samples harvested at 4 months
Micro-CT Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: bone volume / tissue volume (BV/TV)
Samples harvested at 4 months
Micro-CT Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: trabecular number
Samples harvested at 4 months
Micro-CT Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: trabecular separation
Samples harvested at 4 months
Micro-CT Parameters
Time Frame: Samples harvested at 4 months
Histological analysis of bone cores: trabecular thickness
Samples harvested at 4 months
Patient-reported Parameters
Time Frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
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
Time Frame: Measured before surgery and at 1, 2 and 6 weeks, and 4 months
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
Time Frame: Measured before surgery and at 1, 2 and 6 weeks, and 4 months
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
Time Frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Parameters
Time Frame: Measured at baseline (before surgery)
gingival width
Measured at baseline (before surgery)
Clinical Parameters
Time Frame: Measured at baseline (before surgery)
gingival thickness
Measured at baseline (before surgery)
Clinical Parameters
Time Frame: Measured immediately after surgery, at 1, 2 and 6 weeks and 4 months
wound opening
Measured immediately after surgery, at 1, 2 and 6 weeks and 4 months
Clinical Parameters
Time Frame: Measured at 1, 2 and 6 weeks and 4 months
bleeding
Measured at 1, 2 and 6 weeks and 4 months
Clinical Parameters
Time Frame: Measured at 1, 2 and 6 weeks and 4 months
grafting material discharge
Measured at 1, 2 and 6 weeks and 4 months
Clinical Parameters
Time Frame: Measured at 1, 2 and 6 weeks and 4 months
flap necrosis
Measured at 1, 2 and 6 weeks and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marquette University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LifeNet Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vrisiis Kofina, DDS, MS, Marquette University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR-4728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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