Chronic PeriodontitisNCT03621891
Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma
An observational study of Chronic Periodontitis and Occlusal Trauma, run by Tokat Gaziosmanpasa University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 29 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Occlusal Trauma
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2016to 1 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Smoking
- Pregnancy/lactation
- Systemical disease
- Drug use
- Absence of at least 20 functioning teeth
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gaziosmanpasa University Faculty of Dentistry
Tokat Province, 60100
Gaziosmanpasa University
Tokat Province, 60100
About this study
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.
- Conditions
- Chronic Periodontitis, Occlusal Trauma
- Keywords
- hyper-occlusion, hypoxia, occlusal trauma, periodontitis, subgingival microbiota
- Medical subject headings
- Chronic Periodontitis, Hypoxia, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Determination of certain bacterial species in subgingival dental plaque
Subgingival dental plaque samples were collected from each participant and evaluated via polymerase-chain reaction.
Measured: 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
Measured: One day after initial examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 May 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Balci Yuce, Tokat Gaziosmanpasa University
- Investigators
- HATICE BALCI YUCE, PhD, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621891
- Sponsor's protocol ID
- balciyuce84
- Status last verified
- Aug 2018
- First submitted
- 4 Aug 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma
- ClinicalTrials.gov ID
- NCT03621891
- Acronym / sponsor ID
- balciyuce84
- Conditions
- Chronic Periodontitis, Occlusal Trauma
- Keywords
- hyper-occlusion, hypoxia, occlusal trauma, periodontitis, subgingival microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 29 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Systemical health
- No drug use
- No pregnancy or lactation For group 3 and 4;
- Bruxism at least for 2 years
- Occlusal trauma
Key exclusion criteria (5 listed)
- Smoking
- Pregnancy/lactation
- Systemical disease
- Drug use
- Absence of at least 20 functioning teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
hypoxic changes in gingiva and serum
Time frame: One day after initial examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HATICE BALCI YUCE, PhD principal investigator
Gaziosmanpasa University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Occlusal Trauma, run by Tokat Gaziosmanpasa University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of certain bacterial species in subgingival dental plaque (time frame: A day after initial examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.