- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625414
Tissue Alterations in Aggressive and Chronic Periodontitis
August 9, 2018 updated by: Hatice Balci Yuce, Tokat Gaziosmanpasa University
Comparison of the Physiologic and Biochemical Alterations in the Healthy and Affected Sites of Chronic and Aggressive Periodontitis Patients
Present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals.
The investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased fibroblast cell counts and increased inflammatory cell counts.
Investigators also suggest that a possible mechanism which might play a role in the disease progression might occur via a disbalance between matrix metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.
Study Overview
Status
Completed
Detailed Description
Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue.
The etiology and pathogenesis of chronic periodontitis are mostly revealed however, there are many dark points in the etiopathogenesis of aggressive periodontitis.
The existence of periodontal destruction at even one tooth in the mouth increases the risk of further periodontal destruction.
However, the incidence of progression of the disease to the unaffected teeth was not demonstrated.
Yet, the progression of the disease from diseased sites to healthy sites is likely to occur but no evidence is present comparing healthy and diseased sites of chronic and aggressive periodontitis.
Present study aimed to evaluate the histological changes in both diseased and healthy sites in both localized aggressive periodontitis (LAgP) and chronic periodontitis (CP) patients by determining fibroblast and inflammatory cell counts in histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to better understand the dimensions of this demolition in periodontal disease.
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokat, Turkey, 60100
- Gaziosmanpasa University Faculty of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy individuals, chronic periodontitis patients, and localized aggressive periodontitis patients older than 30 years old and younger than 45 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.
Description
Inclusion Criteria:
Age range from 30 to 45, the existence of at least 20 functioning teeth, no history of smoking, systemical health, no antibiotic use within 6 months, no periodontal therapy within 6 months, no pregnancy or lactation, no drug use, in addition; For healthy individuals, the existence of oral health
- For localized aggressive periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
- For chronic periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
Exclusion Criteria:
- Patients younger than 30 older than 45 years old, the absence of occlusion, drug use, pregnancy/lactation, smoking, previous antibiotic use, previous periodontal therapy, the existence of any systemical disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy individuals
Gingival biopsies of healthy individuals who had no systemic or oral disease or condition.
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Unaffected sites of CP
Chronic periodontitis patients had teeth affected from destruction and some teeth were unaffected.
Gingival biopsies of chronic periodontitis patients were taken from sites which were not affected by periodontal destruction.
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Affected sites of CP
Chronic periodontitis patients had teeth affected from destruction and some teeth were unaffected.
Gingival biopsies of chronic periodontitis patients were taken from sites which were affected by periodontal destruction.
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Unaffected sites of LAgP
Like chronic periodontitis, aggressive periodontitis patients had also teeth affected by destruction and some teeth were unaffected.
Gingival biopsies of aggressive periodontitis patients were taken from sites which were not affected by the periodontal destruction.
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Affected sites of LAgP
Like chronic periodontitis, aggressive periodontitis patients had also teeth affected by destruction and some teeth were unaffected.
Gingival biopsies of aggressive periodontitis patients were taken from sites which were affected by the periodontal destruction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Fibroblast and total inflammatory cell counts
Time Frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
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Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.
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Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Immunohistochemical staining
Time Frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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Expressions of matrix metalloproteinase 8 and tissue inhibitor, hypoxia inducible factor-1alpha and vascular endothelial growth factor were evaluated in histological slides.
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Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: HATİCE BALCI YÜCE, PhD, Gaziosmanpasa University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Actual)
August 13, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- balciyuce
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.