Periodontal DiseasesNCT03442920
Evaluation of Periodontal Diseases and Obesity in Women
A study testing Exercise in people with Periodontal Diseases and Obesity, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)]. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2014to 10 Jan 2016
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being women,
- Older than 18 yrs old,
- Not being pregnant,
- Not being disabled,
- For study group; being obese, not for healthy group being systemically health and in normal weight
- Not treated periodontological in the last 6 months
Who cannot join
- Younger than 18 yrs old,
- Smokers who smokes more than 10 cigarettes in a day,
- Uncontrolled systemic diseases,
- Having periodontal treatment
- who needs antibiotic prophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects
The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].
Read the detailed description
It is thought that adipokines may play a role on periodontal disease in obese subjects, periodontal disease may also aggravate the existing systemic disease by changing the inflammatory parameters in the body. The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].
- Conditions
- Periodontal Diseases, Obesity
- Being tested
- Exercise
- Keywords
- obesity, periodontal diseases, gingival crevicular fluid, saliva, serum
- Medical subject headings
- Periodontal Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
This group made exercise for 12 week/3 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Obese women | Experimental | Obese women who participated exercise programme. Receives: Other: Exercise |
| Normal weighted | No intervention | Normal weighted women with non-periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical variables GCF
TNF-A, IL-1B,concentrations levels (pg/µl)
Measured: 12 week
Biochemical variables GCF
Leptin, adiponectin, resistin concentrations levels (ng/µl)
Measured: 12 week
Secondary outcomes (4)
Biochemical variables_Saliva
TNF-A, IL-1B,concentrations levels (pg/µl)
Measured: 12 week
Biochemical variables_Saliva
leptin, adiponectin, resistin concentrations levels (ng/µl)
Measured: 12 week
Biochemical variables_Serum
TNF-A, IL-1B,concentrations levels (pg/µl)
Measured: 12 week
Biochemical variables_Serum
leptin, adiponectin, resistin concentrations levels (ng/µl)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start29 Dec 2014
- Primary completion11 Jun 2015
- Study completion10 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Esra Guzeldemir-Akcakanat, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442920
- Sponsor's protocol ID
- 114S144
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 22 Feb 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 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects
- ClinicalTrials.gov ID
- NCT03442920
- Acronym / sponsor ID
- 114S144
- Conditions
- Periodontal Diseases, Obesity
- Keywords
- obesity, periodontal diseases, gingival crevicular fluid, saliva, serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 29 Dec 2014 (actual)
- Primary completion
- 11 Jun 2015 (actual)
- Study completion
- 10 Jan 2016 (actual)
- First posted
- 22 Feb 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.
The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].
Detailed description
It is thought that adipokines may play a role on periodontal disease in obese subjects, periodontal disease may also aggravate the existing systemic disease by changing the inflammatory parameters in the body. The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese women | Experimental | Other: ExerciseObese women who participated exercise programme. |
| Normal weighted | No intervention | –Normal weighted women with non-periodontitis |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being women,
- Older than 18 yrs old,
- Not being pregnant,
- Not being disabled,
- For study group; being obese, not for healthy group being systemically health and in normal weight
Key exclusion criteria (5 listed)
- Younger than 18 yrs old,
- Smokers who smokes more than 10 cigarettes in a day,
- Uncontrolled systemic diseases,
- Having periodontal treatment
- who needs antibiotic prophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThis group made exercise for 12 week/3 times a week. | Other | Obese women |
Primary outcome
Biochemical variables GCF
Time frame: 12 week
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables GCF
Time frame: 12 week
Leptin, adiponectin, resistin concentrations levels (ng/µl)
4 secondary outcomes
Biochemical variables_Saliva
Time frame: 12 week
Biochemical variables_Saliva
Time frame: 12 week
Biochemical variables_Serum
Time frame: 12 week
Biochemical variables_Serum
Time frame: 12 week
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 22 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Periodontal Diseases and Obesity, run by Kocaeli University at 1 site 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Biochemical variables GCF (time frame: 12 week). The study lists 2 primary outcomes in all. 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 22 Feb 2018.