Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma

NCT03621891 | Completed

• 1 other identifier: balciyuce84
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Periodontitis; Occlusal Trauma

Keywords

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

Outcome Measures

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.

  A day after initial examination

Secondary Outcomes (1)

• hypoxic changes in gingiva and serum

  One day after initial examination

Study Arms (4)

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

Eligibility Criteria

• Age: 29 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (2)

Gaziosmanpasa University Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid, serum

MeSH Terms

Conditions

Chronic Periodontitis; Hypoxia; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• HATICE BALCI YUCE, PhD

  Gaziosmanpasa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, principal investigator

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 9, 2018
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

TU (2)