Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07372183

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marquette University School of Dentistry Graduate Periodontics Clinic

Milwaukee, Wisconsin, 53233, United States

Location contact

Arndt Guentsch, DMD, PhD, MHBA, MS

CONTACT

[email protected]

4142886089

Vrisiis Kofina, DDS, MS

CONTACT

[email protected]

4142886521

Vrisiis Kofina, DDS, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

observational study

Other

Observational study; alveolar ridge preservation

Primary outcomes

  1. Clinical Parameters

    Time frame: Measured before surgery, during surgery and at 4 months

    bone width

  2. Clinical Parameters

    Time frame: Measured before surgery, during surgery and at 4 months

    bone height

Secondary outcomes

  1. Genetic Parameters

    Time frame: Bone samples harvested at 4 months

    RNA transcriptomic analysis

  2. Histological Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: %mineralized bone

  3. Histological Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: %osteoid

  4. Histological Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: %residual bone graft

  5. Histological Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: %soft tissue

  6. Histological Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: numbers of osteoblasts and osteoclasts

  7. Micro-CT Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: bone mineral density

  8. Micro-CT Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: tissue mineral density

  9. Micro-CT Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: bone volume / tissue volume (BV/TV)

  10. Micro-CT Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: trabecular number

  11. Micro-CT Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: trabecular separation

  12. Micro-CT Parameters

    Time frame: Samples harvested at 4 months

    Histological analysis of bone cores: trabecular thickness

  13. 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).

  14. 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.

  15. 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.

  16. 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.

Other outcomes

  1. Clinical Parameters

    Time frame: Measured at baseline (before surgery)

    gingival width

  2. Clinical Parameters

    Time frame: Measured at baseline (before surgery)

    gingival thickness

  3. Clinical Parameters

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

    wound opening

  4. Clinical Parameters

    Time frame: Measured at 1, 2 and 6 weeks and 4 months

    bleeding

  5. Clinical Parameters

    Time frame: Measured at 1, 2 and 6 weeks and 4 months

    grafting material discharge

  6. Clinical Parameters

    Time frame: Measured at 1, 2 and 6 weeks and 4 months

    flap necrosis

Study contacts

Contact information is provided by the study sponsor or research team.

McKenna Schnack, DDS, MS

CONTACT

[email protected]

515-822-3552

Vrisiis Kofina, DDS, MS

CONTACT

[email protected]

516-817-0393

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Collaborators

  • LifeNet Health

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.