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Tissue Alterations in Aggressive and Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT03625414
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hatice Balci Yuce, Tokat Gaziosmanpasa University

Brief Summary:
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.

Condition or disease
Localized Aggressive Periodontitis Chronic Periodontitis

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.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the Physiologic and Biochemical Alterations in the Healthy and Affected Sites of Chronic and Aggressive Periodontitis Patients
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : June 1, 2018

Group/Cohort
Healthy individuals
Gingival biopsies of healthy individuals who had no systemic or oral disease or condition.
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.
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.
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.
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.



Primary Outcome Measures :
  1. Fibroblast and total inflammatory cell counts [ Time Frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after. ]
    Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.


Secondary Outcome Measures :
  1. Immunohistochemical staining [ Time Frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after ]
    Expressions of matrix metalloproteinase 8 and tissue inhibitor, hypoxia inducible factor-1alpha and vascular endothelial growth factor were evaluated in histological slides.


Biospecimen Retention:   Samples Without DNA
Gingival biopsies around teeth either affected by periodontal destruction or unaffected. And gingival biopsies of healthy individuals were also obtained.


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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625414


Locations
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Turkey
Gaziosmanpasa University Faculty of Dentistry
Tokat, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: HATİCE BALCI YÜCE, PhD Gaziosmanpasa University

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Responsible Party: Hatice Balci Yuce, Dr, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT03625414     History of Changes
Other Study ID Numbers: balciyuce
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontitis
Aggression
Chronic Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms