Apoptotic Changes in Gingiva Caused by Smoking

NCT03631498 | Completed

• 1 other identifier: Ozkan
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. The investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients. One possible mechanism for this is suggested to be increased apoptosis.

Conditions

Smoking; Chronic Periodontitis

Keywords

smoking; hypoxia; apoptosis; chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• Fibroblast and total inflammatory cell counts

  Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.

  Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.

Secondary Outcomes (2)

• Apoptotic markers

  Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after

• Hypoxia and tissue destruction markers

  Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after

Study Arms (4)

Healthy individuals

Gingival biopsies of healthy individuals who were never-smokers and had no systemic or oral disease or condition.

periodontitis patients

Gingival biopsies of periodontitis patients who were never-smokers and had no systemic disease or condition.

Healthy smokers

Gingival biopsies of healthy individuals who were smokers but no systemic or oral disease or condition.

Smokers with periodontitis

Gingival biopsies of periodontitis patients who were smokers but no systemic disease or condition.

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy individuals who were either smokers or non-smokers, chronic periodontitis patients who were either smokers or non-smokers older than 30 years old and younger than 50 years old were enrolled. The age was specifically chosen because aging changes periodontal and gingival tissues independently of other variables. Any possible factor which might alter connective tissue metabolism were excluded.

You may qualify if:

• Age range from 30 to 45,
• the existence of at least 20 functioning teeth,
• systemical health,
• no antibiotic use within 6 months,
• no periodontal therapy within 6 months,
• no pregnancy or lactation,
• no drug use, in addition; for the smokers existence of the smoking condition for at least five years.

You may not qualify if:

• Patients younger than 30 older than 50 years old,
• the absence of occlusion,
• drug use,
• pregnancy/lactation,
• previous antibiotic use,
• previous periodontal therapy,
• the existence of any systemical disease.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Gaziosmanpasa University Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival tissue biopsy samples

MeSH Terms

Conditions

Smoking; Chronic Periodontitis; Hypoxia

Condition Hierarchy (Ancestors)

Behavior; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• HATİCE BALCI YÜCE, PhD

  Gaziosmanpasa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: January 10, 2017
• Primary Completion: January 10, 2018
• Study Completion: April 10, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

TU (1)