ObesityEarly Phase 1NCT02563171
Gingival Crevicular Fluid Vaspin and Omentin Levels in Obese Patients With Chronic Periodontitis
A Early Phase 1 study testing non surgical periodontal treatment and Gingival crevicular fluid collection in people with Obesity and Periodontitis, run by Umut BALLI.
Trial summary
Our objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with chronic periodontitis in order to determine the usefulness of vaspin and omentin as a diagnostic and prognostic biomarker of… Read more about this study
- Who is it for?
- Ages 30 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Periodontitis
- What is being tested?
- non surgical periodontal treatment and Gingival crevicular fluid collection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to May 2015
- Phase
- Early Phase 1
- 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 30 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1-) 30-49 years of age 2-) had a minimum of 20 natural teeth, excluding third molars 3) glycosylated hemoglobi levels <6% 4) fasting plasma glucose levels <100 mg/dl. 5-) Criteria for the periodontal healthy group were GI = 0, PPD≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination.
- 6-) Criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), GI ≥ 2, PPD and CAL ≥ 5 mm, and bone loss affecting >30% of the existing teeth on clinical and radiographic examination.
- 7-) Criteria for obese groups were 30≤ BMI <40 kg/m2, and concomitant WHR ≥0.85 for females and WHR ≥0.90 for males.
- 8-) Criteria for normal-weight groups were 20≤ BMI <25 kg/m2, and WHR below that determined for obesity.
Who cannot join
- Aggressive periodontitis,
- Periapical pathologies
- Excessive forces including mechanical forces from orthodontics and occlusion
- Systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions)
- Chronic high-dose steroid therapy, radiation or immunosuppressive therapy
- Pregnancy, lactation,
- Smoking within the past five years, or allergy or sensitivity to any drug.
- Had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months.
About this study
Official title: Effects of Non-Surgical Periodontal Treatment on the Gingival Crevicular Fluid Levels of Vaspin and Omentin-1 in Obese Patients With Chronic Periodontitis
Our objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with chronic periodontitis in order to determine the usefulness of vaspin and omentin as a diagnostic and prognostic biomarker of periodontal disease.
Read the detailed description
All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on the periodontal and anthropometric measurements, individuals (n=76) were divided into four groups: the periodontal-healthy group (n=19), chronic periodontitis group (n=19), periodontal-healthy with obesity group (n=19) and chronic periodontitis with obesity group (n=19). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. Vaspin, omentin, and TNF-α levels were measured by enzyme-linked immunosorbent assay.
- Conditions
- Obesity, Periodontitis
- Being tested
- non surgical periodontal treatment, Gingival crevicular fluid collection
- Keywords
- visceral adipose-specific serpin, intelectin 1 (omentin), Tumor Necrosis Factor-alpha
- Medical subject headings
- Obesity, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical periodontal treatmentOther
- SRP under local anaesthesia, in a total of 2-3 clinical visits.
- Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
Gingival crevicular fluid collectionOther
GCF collection with filter paper (Periopaper) using the intracrevicular method.
| Study group | Role | What they receive |
|---|---|---|
| Healthy periodontium without obesity | Placebo comparator | GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection Receives: Other: Gingival crevicular fluid collection |
| Chronic periodontitis without obesity | Active comparator | GCF samples were taken before and after treatment chronic periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) Receives: Other: non surgical periodontal treatment |
| Healthy periodontium with obesity | Placebo comparator | GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection Receives: Other: Gingival crevicular fluid collection |
| Chronic periodontitis with obesity | Active comparator | GCF samples were taken before and after treatment chronic periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) Receives: Other: non surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameters (Vaspin and omentin)
The changes in levels of vaspin and omentin 6 weeks after periodontal treatment determined by ELISA. The changes in levels of vaspin and omentin were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontal disease.
Measured: Baseline and 6 weeks after treatment
Secondary outcomes (6)
Tumor necrosis factor alfa
The changes in levels of tumor necrosis factor alfa 6 weeks after periodontal treatment determined by ELISA.
Measured: Baseline and 6 weeks after treatment
Probing pocket depth
The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Measured: Baseline and 6 weeks after treatment
Clinical attachment level
The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Measured: Baseline and 6 weeks after treatment
Gingival index
The changes in gingival index after periodontal treatment. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation. Also, gingival index was also analyzed to detect the relationship between vaspin, omentin and tumor necrosis factor alfa.
Measured: Baseline and 6 weeks after treatment
Plaque index
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Measured: Baseline and 6 weeks after treatment
Bleeding on probing
The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Measured: Baseline and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umut BALLI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Umut BALLI, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563171
- Sponsor's protocol ID
- 2014-115-17/06
- Status last verified
- Sep 2015
- First submitted
- 28 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-Surgical Periodontal Treatment on the Gingival Crevicular Fluid Levels of Vaspin and Omentin-1 in Obese Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT02563171
- Acronym / sponsor ID
- 2014-115-17/06
- Conditions
- Obesity, Periodontitis
- Keywords
- visceral adipose-specific serpin, intelectin 1 (omentin), Tumor Necrosis Factor-alpha
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Umut BALLIUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
Our objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with chronic periodontitis in order to determine the usefulness of vaspin and omentin as a diagnostic and prognostic biomarker of periodontal disease.
Detailed description
All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on the periodontal and anthropometric measurements, individuals (n=76) were divided into four groups: the periodontal-healthy group (n=19), chronic periodontitis group (n=19), periodontal-healthy with obesity group (n=19) and chronic periodontitis with obesity group (n=19). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. Vaspin, omentin, and TNF-α levels were measured by enzyme-linked immunosorbent assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy periodontium without obesity | Placebo comparator | Other: Gingival crevicular fluid collectionGCF samples were taken at baseline Intervention: Gingival crevicular fluid collection |
| Chronic periodontitis without obesity | Active comparator | Other: non surgical periodontal treatmentGCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) |
| Healthy periodontium with obesity | Placebo comparator | Other: Gingival crevicular fluid collectionGCF samples were taken at baseline Intervention: Gingival crevicular fluid collection |
| Chronic periodontitis with obesity | Active comparator | Other: non surgical periodontal treatmentGCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1-) 30-49 years of age 2-) had a minimum of 20 natural teeth, excluding third molars 3) glycosylated hemoglobi levels <6% 4) fasting plasma glucose levels <100 mg/dl. 5-) Criteria for the periodontal healthy group were GI = 0, PPD≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination.
- 6-) Criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), GI ≥ 2, PPD and CAL ≥ 5 mm, and bone loss affecting >30% of the existing teeth on clinical and radiographic examination.
- 7-) Criteria for obese groups were 30≤ BMI <40 kg/m2, and concomitant WHR ≥0.85 for females and WHR ≥0.90 for males.
- 8-) Criteria for normal-weight groups were 20≤ BMI <25 kg/m2, and WHR below that determined for obesity.
Key exclusion criteria (8 listed)
- Aggressive periodontitis,
- Periapical pathologies
- Excessive forces including mechanical forces from orthodontics and occlusion
- Systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions)
- Chronic high-dose steroid therapy, radiation or immunosuppressive therapy
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 |
|---|---|---|
| non surgical periodontal treatment1. SRP under local anaesthesia, in a total of 2-3 clinical visits. 2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush. | Other | Chronic periodontitis with obesity, Chronic periodontitis without obesity |
| Gingival crevicular fluid collectionGCF collection with filter paper (Periopaper) using the intracrevicular method. | Other | Healthy periodontium with obesity, Healthy periodontium without obesity |
Primary outcome
Biochemical parameters (Vaspin and omentin)
Time frame: Baseline and 6 weeks after treatment
The changes in levels of vaspin and omentin 6 weeks after periodontal treatment determined by ELISA. The changes in levels of vaspin and omentin were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontal disease.
6 secondary outcomes
Tumor necrosis factor alfa
Time frame: Baseline and 6 weeks after treatment
Probing pocket depth
Time frame: Baseline and 6 weeks after treatment
Clinical attachment level
Time frame: Baseline and 6 weeks after treatment
Gingival index
Time frame: Baseline and 6 weeks after treatment
Plaque index
Time frame: Baseline and 6 weeks after treatment
Bleeding on probing
Time frame: Baseline and 6 weeks after treatment
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 30 Sep 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing non surgical periodontal treatment and Gingival crevicular fluid collection in people with Obesity and Periodontitis, run by Umut BALLI.
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 4 inclusion and 8 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 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 parameters (Vaspin and omentin) (time frame: Baseline and 6 weeks after treatment). 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 30 Sep 2015.