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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMarquette University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • observational study

    Other intervention

    Observational study; alveolar ridge preservation

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Smokers1 intervention
Group B: Non-smokers1 intervention

Trial outcomes

Primary outcomes

1

Clinical Parameters

bone width

Time frame
Measured before surgery, during surgery and at 4 months
2

Clinical Parameters

bone height

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

Secondary outcomes

1

Genetic Parameters

RNA transcriptomic analysis

Time frame
Bone samples harvested at 4 months
2

Histological Parameters

Histological analysis of bone cores: %mineralized bone

Time frame
Samples harvested at 4 months
3

Histological Parameters

Histological analysis of bone cores: %osteoid

Time frame
Samples harvested at 4 months
4

Histological Parameters

Histological analysis of bone cores: %residual bone graft

Time frame
Samples harvested at 4 months

Other outcomes

1

Clinical Parameters

gingival width

Time frame
Measured at baseline (before surgery)
2

Clinical Parameters

gingival thickness

Time frame
Measured at baseline (before surgery)
3

Clinical Parameters

wound opening

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

Clinical Parameters

bleeding

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

Sponsors and contacts

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Marquette University

Lead sponsor

LifeNet Health

Collaborator

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