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CompletedNCT03621891Updated Aug 10, 2018

Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma

An observational study in Chronic Periodontitis and Occlusal Trauma, sponsored by Tokat Gaziosmanpasa University. Completed at 2 sites in Turkey. Open to participants aged 29 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-10.

Sponsored by Tokat Gaziosmanpasa University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
29 Years to 42 Years
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Chronic Periodontitis
  • Occlusal Trauma

Keywords

  • hyper-occlusion
  • hypoxia
  • occlusal trauma
  • periodontitis
  • subgingival microbiota
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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Tokat Gaziosmanpasa University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
29 Years to 42 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Smoking
  • Pregnancy/lactation
  • Systemical disease
  • Drug use
  • Absence of at least 20 functioning teeth
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Determination of certain bacterial species in subgingival dental plaque

    Subgingival dental plaque samples were collected from each participant and evaluated via polymerase-chain reaction.

    Time frame: A day after initial examination

Secondary outcomes

  1. hypoxic changes in gingiva and serum

    Determination of the hypoxia inducible factor-alpha and vascular endothelial growth factor via ELISA

    Time frame: One day after initial examination

07

Study locations

2 sites
  • Gaziosmanpasa University Faculty of Dentistry
    Tokat, 60100, Turkey
  • Gaziosmanpasa University
    Tokat, 60100, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03621891
Lead sponsor
Tokat Gaziosmanpasa University
Responsible party
Hatice Balci Yuce (Dr, principal investigator, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Aug 9, 2018
Start date
May 1, 2016
Primary completion
May 1, 2017
Completion
May 1, 2017
Last update
Aug 10, 2018

Study contacts

HATICE BALCI YUCE, PhD
principal investigator · Gaziosmanpasa University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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