NCT03625414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 7, 2018

Last Update Submit

August 9, 2018

Conditions

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 (1)

  • Immunohistochemical staining

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

Study Arms (5)

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.

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • HATİCE BALCI YÜCE, PhD

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

February 1, 2017

Primary Completion

February 1, 2018

Study Completion

June 1, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations