ObesityNCT04743336
The Relationship Between Body Mass Index and Periodontitis
An observational study of Obesity and Periodontitis, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the relationship between body mass index (BMI) and stage/grade of periodontitis per the current classification of periodontal diseases. 142 patients (82 males/60 females) were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Periodontitis
- What is being tested?
- Measuring pocket depth
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Feb 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021
Who may be able to join
- patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021
Who cannot join
- being under the age of 18,
- being pregnant,
- having used antibiotics within the past 3 months,
- having missing data in dental and medical records.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University,Department of Dentistry
Ankara
About this study
Official title: The Relationship Between Body Mass Index and Stage/Grade of Periodontitis
This study aimed to examine the relationship between body mass index (BMI) and stage/grade of periodontitis per the current classification of periodontal diseases.
142 patients (82 males/60 females) were included in this study. "2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" was taken as basis to characterize the stage/grade of periodontitis. As well as age, gender, smoking status, and frequency of tooth brushing, medical data of the patients including hypertension, hyperlipidemia, BMI, and diabetes mellitus were obtained from the patient's hospital records. Obesity was assessed by BMI using the "World Health Organization" criteria.
Read the detailed description
In this retrospective study, dental and medical records of 200 patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021 were reviewed. Fifty three patients were excluded due to unclear or missing data, and five subjects were not included as they were under the age of 18. The final study population therefore consisted of 142 patients (82 males/60 females).
As well as age, gender, smoking status, and frequency of tooth brushing, medical data of the patients including hypertension, hyperlipidemia, BMI, and diabetes mellitus were obtained from the patient's hospital records.
Periodontal records of the patients were obtained for six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth.
Mean ± standard deviation (SD) and median (minimum-maximum) were utilized for quantitative variables, and number of patients (percentage) were utilized for qualitative variables as descriptors. For quantitative variables, Kruskal-Wallis H test was performed to see whether there was a statistically significant difference between categories of the qualitative variable with more than two categories. Chi-square test was used for investigating the relationship between two qualitative variables. For determining the risk factors considered to have an effect on the dependent quantitative variable, univariate and multivariate logistic regression analyses were performed. Statistical significance level was defined to be 0.05.
- Conditions
- Obesity, Periodontitis
- Being tested
- Measuring pocket depth
- Medical subject headings
- Obesity, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring pocket depthOther
Probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar
| Study group | Role | What they receive |
|---|---|---|
| Normal weight (<25 kg/m2) | Not described Receives: Other: Measuring pocket depth | |
| overweight (25-29.9 kg/m2) | Not described Receives: Other: Measuring pocket depth | |
| obese (≥30 kg/m2) | Not described Receives: Other: Measuring pocket depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Jan 2019
- Primary completion15 Jan 2021
- Study completion1 Feb 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Bilgin Çetin, Baskent University
- Investigators
- Mehtap Bilgin Çetin, DDS,PhD, Principal investigator, Department of Periodontology, Faculty of Dentistry, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743336
- Sponsor's protocol ID
- MBÇ
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Body Mass Index and Stage/Grade of Periodontitis
- ClinicalTrials.gov ID
- NCT04743336
- Acronym / sponsor ID
- MBÇ
- Conditions
- Obesity, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 8 Feb 2021 (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.
This study aimed to examine the relationship between body mass index (BMI) and stage/grade of periodontitis per the current classification of periodontal diseases.
142 patients (82 males/60 females) were included in this study. "2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" was taken as basis to characterize the stage/grade of periodontitis. As well as age, gender, smoking status, and frequency of tooth brushing, medical data of the patients including hypertension, hyperlipidemia, BMI, and diabetes mellitus were obtained from the patient's hospital records. Obesity was assessed by BMI using the "World Health Organization" criteria.
Detailed description
In this retrospective study, dental and medical records of 200 patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021 were reviewed. Fifty three patients were excluded due to unclear or missing data, and five subjects were not included as they were under the age of 18. The final study population therefore consisted of 142 patients (82 males/60 females).
As well as age, gender, smoking status, and frequency of tooth brushing, medical data of the patients including hypertension, hyperlipidemia, BMI, and diabetes mellitus were obtained from the patient's hospital records.
Periodontal records of the patients were obtained for six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth.
Mean ± standard deviation (SD) and median (minimum-maximum) were utilized for quantitative variables, and number of patients (percentage) were utilized for qualitative variables as descriptors. For quantitative variables, Kruskal-Wallis H test was performed to see whether there was a statistically significant difference between categories of the qualitative variable with more than two categories. Chi-square test was used for investigating the relationship between two qualitative variables. For determining the risk factors considered to have an effect on the dependent quantitative variable, univariate and multivariate logistic regression analyses were performed. Statistical significance level was defined to be 0.05.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight (<25 kg/m2) | – | Other: Measuring pocket depth |
| overweight (25-29.9 kg/m2) | – | Other: Measuring pocket depth |
| obese (≥30 kg/m2) | – | Other: Measuring pocket depth |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021
Key inclusion criteria (1 listed)
- patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021
Key exclusion criteria (4 listed)
- being under the age of 18,
- being pregnant,
- having used antibiotics within the past 3 months,
- having missing data in dental and medical records.
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 |
|---|---|---|
| Measuring pocket depthProbing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar | Other | Normal weight (<25 kg/m2), obese (≥30 kg/m2), overweight (25-29.9 kg/m2) |
Primary outcome
Probing pocket depth (PPD)
Time frame: 20 minutes
Probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar
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 8 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Mehtap Bilgin Çetin, DDS,PhD principal investigator
Department of Periodontology, Faculty of Dentistry, Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Periodontitis, run by Baskent 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 1 inclusion and 4 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 8 Feb 2021. 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?
Probing pocket depth (PPD) (time frame: 20 minutes). 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 8 Feb 2021.