- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621891
Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Tokat, Turkey, 60100
- Gaziosmanpasa University Faculty of Dentistry
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Tokat, Turkey, 60100
- Gaziosmanpasa University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population consisted of 80 participants and 4 study groups were created as follows:
Group 1; healthy individuals without occlusal trauma (Group 1, n=20), 6 men and 14 women, mean age 32.06±2.90 Group 2; periodontitis patients without occlusal trauma (Group 2, n=20), 6 men and 14 women, mean age 36.90±4.67 Group 3; healthy individuals with occlusal trauma (Group 3, n=20), 5 men and 15 women, mean age 34.89±7.51 Group 4; periodontitis patients with occlusal trauma (Group 4, n=20) 7 men and 13 women, mean age 36.76±4.40.
Description
Inclusion Criteria:
- Systemical health
- No drug use
- No pregnancy or lactation For group 3 and 4;
- Bruxism at least for 2 years
- Occlusal trauma
- Existence of at least 20 functioning teeth
Exclusion Criteria:
- Smoking
- Pregnancy/lactation
- Systemical disease
- Drug use
- Absence of at least 20 functioning teeth
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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healthy individuals
Orally and systemically healthy individuals who has no hypo-functional teeth, hyper-occlusion or occlusal trauma
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periodontitis patients
Systemically healthy individuals who has chronic periodontitis but no hypo-functional teeth, hyper-occlusion or occlusal trauma
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healthy-occlusal trauma
Orally and systemically healthy individuals who has occlusal trauma caused by bruxism
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periodontitis-occlusal trauma
Systemically healthy individuals who has both chronic periodontitis and occlusal trauma caused by bruxism
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of certain bacterial species in subgingival dental plaque
Time Frame: A day after initial examination
|
Subgingival dental plaque samples were collected from each participant and evaluated via polymerase-chain reaction.
|
A day after initial examination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hypoxic changes in gingiva and serum
Time Frame: One day after initial examination
|
Determination of the hypoxia inducible factor-alpha and vascular endothelial growth factor via ELISA
|
One day after initial examination
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HATİCE BALCI YÜCE, PhD, Gaziosmanpasa University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- balciyuce84
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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