Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma

• ClinicalTrials.gov Identifier: NCT03621891
• Recruitment Status: Completed
• First Posted: August 9, 2018
• Last Update Posted: August 10, 2018
• Sponsor: Tokat Gaziosmanpasa University
• Information provided by (Responsible Party): Hatice Balci Yuce, Tokat Gaziosmanpasa University

Study Description

Brief 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.

Condition or disease
Chronic Periodontitis; Occlusal Trauma

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 Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Biospecimen Retention:   Samples Without DNA

Gingival crevicular fluid, serum

Eligibility Criteria

• Ages Eligible for Study: 29 Years to 42 Years (Adult)
• Sexes Eligible for Study: 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.

Criteria

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

Contacts and Locations

Locations

Turkey

Gaziosmanpasa University Faculty of Dentistry

Tokat, Turkey, 60100

Gaziosmanpasa University

Tokat, Turkey, 60100

Sponsors and Collaborators

Tokat Gaziosmanpasa University

Investigators

• Principal Investigator: HATICE BALCI YUCE, PhD; Gaziosmanpasa University

More Information

• Responsible Party: Hatice Balci Yuce, Dr, principal investigator, Tokat Gaziosmanpasa University
• ClinicalTrials.gov Identifier: NCT03621891
• Other Study ID Numbers: balciyuce84
• First Posted: August 9, 2018
• Last Update Posted: August 10, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hatice Balci Yuce, Tokat Gaziosmanpasa University:

hyper-occlusion; hypoxia; occlusal trauma; periodontitis; subgingival microbiota

Additional relevant MeSH terms:

Periodontitis; Chronic Periodontitis; Hypoxia; Wounds and Injuries; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Respiratory