Effects of Smoking on Oral Tissue Samples

NCT05484765 | Completed

• 1 other identifier: ESGHDEOECP
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking negatively affects the prognosis of periodontal disease by impairing tissue healing. While micronucleus is the most popular parameter for demonstrating DNA damage, inflammatory cell and vascular densities are the most evaluated parameters for determining histopathologic changes in the periodontium. This cross-sectional study aimed to evaluate the effects of heavy cigarette smoking and generalized periodontitis on local genotoxic damage to exfoliated oral epithelial cells as well as histopathologic damage to the periodontium. The investigators hypothesized that the genotoxic and histopathologic damage would be increased in smokers with generalized periodontitis.

Conditions

Histopathology; Periodontitis; Smoking; Micronuclei

Outcome Measures

Primary Outcomes (2)

• Micronuclei counts

  During mitosis, loss of chromatin from chromosomal DNA is manifested by extra-small, abnormal nuclear structures called micronuclei. Of the available cytogenetic analyses, the micronucleus assay is one of the most popular methods for detecting structural and numerical nuclear abnormalities due to its reliability and simplicity. This genotoxic biomonitoring assay makes it possible to provide evidence for the biological assessment of disease susceptibility, diagnosis, and staging in subjects exposed to environmental risk factors.Briefly, smear samples were collected from the attached gingival mucosa of the upper premolar-molar area and the buccal mucosa of the matching cheek using two separate sterile cytobrushes. Samples were fixed on glass slides.

  1 year

• Histopathologic changes

  Histopathologic damage was evaluated by focusing on inflammatory cell and vascular densities.Biopsy samples were taken from the vestibular area of the maxillary molars during tooth extraction or crown lengthening using a 15C surgical blade and fixed in 10% formalin until analysis.

  1 year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects were separated into four groups: smokers with generalized periodontitis (SGP; n = 20), non-smokers with generalized periodontitis (NGP; n = 20), smokers with clinically healthy periodontium (SHP; n = 20), and non-smokers with clinically healthy periodontium (NHP; n = 20). The following criteria needed to be met to be considered a periodontitis subject: the presence of generalized periodontitis, the presence of at least 20 teeth, the presence of a molar with an indication of gingivectomy, crown lengthening or extraction with a PD ≥ 5mm, clinical attachment loss ≥ 5 mm, and the presence of at least ten teeth with a PD ≥ 5 mm. The following criteria indicated a clinically healthy periodontium: a healthy and intact periodontium, no PD and BOP.

You may qualify if:

• Self-reporting as systemically healthy
• Aged between 18-65 years
• The presence of at least five teeth in each quadrant
• To need gingivectomy operations, crown lengthening procedures, or tooth extractions.
• Smokers had used cigarettes for at least five years with daily consumption of ≥ 20.

You may not qualify if:

• The presence of a known medical condition that could possibly bias the results
• Having a medical condition requiring antibiotic prophylaxis for dental treatment
• The presence of systemic medication taken within the previous six months
• Excessive alcohol consumption
• Currently undergoing nicotine replacement therapy
• Consuming tobacco products other than cigarettes
• Those with fixed orthodontic appliances
• History of periodontal therapy

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Begüm Alkan

Istanbul, 34353, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

smear samples, containing exfoliated oral epithelial cells, were taken from buccal and gingival mucosa

MeSH Terms

Conditions

Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Begum Alkan

  Private Practice of Periodontology (formerly Istanbul Medipol University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontology specialist

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: August 2, 2022
• Study Start: November 1, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 20, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

TU (1)