Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma

August 8, 2018 updated by: Hatice Balci Yuce, Tokat Gaziosmanpasa University
Present study suggests that excessive occlusal forces did not cause a significant change in hypoxia and vascular markers, however a slight alteration in subgingival microbiota was observed.

Study Overview

Status

Completed

Detailed Description

Occlusal trauma is defined as tissue destruction and/or injury resulting in tissue changes in the periodontium as a consequence of excessive occlusal forces or hyper-occlusion. Previous studies suggested accelerated periodontal destruction around teeth with occlusal trauma and increased mobility, however, the evidence is lacking. Recent animal studies found that occlusal trauma increased osteoclastic activity and alveolar bone loss. One possible mechanism suggested for the progression of periodontal destruction with occlusal trauma is that tooth mobility creates a subgingival environment conducive to overgrowth by periodontal pathogens. However, the association of occlusal trauma and subgingival microbiota was not evaluated in previous studies. Therefore, present study aimed to evaluate subgingival dental plaque components and compare with healthy individuals and periodontitis patients without occlusal trauma.

Study Type

Observational

Enrollment (Actual)

80

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

      • Tokat, Turkey, 60100
        • Gaziosmanpasa University Faculty of Dentistry
      • Tokat, Turkey, 60100
        • Gaziosmanpasa University

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

29 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
healthy individuals
Orally and systemically healthy individuals who has no hypo-functional teeth, hyper-occlusion or occlusal trauma
periodontitis patients
Systemically healthy individuals who has chronic periodontitis but no hypo-functional teeth, hyper-occlusion or occlusal trauma
healthy-occlusal trauma
Orally and systemically healthy individuals who has occlusal trauma caused by bruxism
periodontitis-occlusal trauma
Systemically healthy individuals who has both chronic periodontitis and occlusal trauma caused by bruxism

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

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

This is where you will find people and organizations involved with this study.

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)

May 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 4, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Chronic Periodontitis

3
Subscribe