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

NCT07372183 | Not Yet Recruiting

• 1 other identifier: HR-4728
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking, Cigarette; Alveolar Bone Grafting; Wound Healing; Bone Healing; Tooth Extraction Site Healing

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (16)

• Genetic Parameters

  Bone samples harvested at 4 months

• Histological Parameters

  Samples harvested at 4 months

• Histological Parameters

  Samples harvested at 4 months

• Histological Parameters

  Samples harvested at 4 months

• Histological Parameters

  Samples harvested at 4 months

Other Outcomes (6)

• Clinical Parameters

  Measured at baseline (before surgery)

• Clinical Parameters

  Measured at baseline (before surgery)

• Clinical Parameters

  Measured immediately after surgery, at 1, 2 and 6 weeks and 4 months

Study Arms (2)

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

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

Interventions

observational study OTHER

Observational study; alveolar ridge preservation

Non-smokers; Smokers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Scheduled for single tooth extraction with bone graft placement and membrane

You may not qualify if:

• Uncontrolled periodontal disease
• Uncontrolled systemic disease
• Pregnancy
• Use of therapy and/or medication that impairs wound healing (e.g., bisphosphonates, steroids, chemotherapy, radiotherapy etc.)

Sponsors & Collaborators

• Marquette University: lead
• LifeNet Health: collaborator

Study Sites (1)

Marquette University School of Dentistry Graduate Periodontics Clinic

Milwaukee, Wisconsin, 53233, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone cores will be harvested at the time of implant placement using trephine drills via surgical guides.

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Observation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Vrisiis Kofina, DDS, MS

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vrisiis Kofina, DDS, MS

CONTACT

516-817-0393; vrisiis.kofina@marquette.edu

McKenna Schnack, DDS, MS

CONTACT

515-822-3552; mckenna.schnack@marquette.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Advanced Education in Periodontics Program, Assistant Professor of Periodontics

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 28, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)