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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03621891
Other study ID # balciyuce84
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2016
Est. completion date May 1, 2017

Study information

Verified date August 2018
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 29 Years to 42 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Gaziosmanpasa University Tokat
Turkey Gaziosmanpasa University Faculty of Dentistry Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of certain bacterial species in subgingival dental plaque Subgingival dental plaque samples were collected from each participant and evaluated via polymerase-chain reaction. A day after initial examination
Secondary hypoxic changes in gingiva and serum Determination of the hypoxia inducible factor-alpha and vascular endothelial growth factor via ELISA One day after initial examination
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