Periodontal DiseasesNCT04682275
Effect of Gender on Depression and Periodontal Status
A study testing Psychological measurements in people with Periodontal Diseases and Depression, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases, Depression, Gender
- What is being tested?
- Psychological measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2017to 12 Feb 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of periodontal diseases
Who cannot join
- the presence of any systemic disease other than depression
- smoking and alcohol consumption
- the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
- have received any periodontal treatment in the last six months
- hormonal condition such as pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.
Read the detailed description
Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.
Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.
- Conditions
- Periodontal Diseases, Depression, Gender, Gingival Diseases
- Being tested
- Psychological measurements
- Keywords
- periodontal diseases, depression, gender, gingival diseases
- Medical subject headings
- Periodontal Diseases, Depression, Coitus, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological measurementsOther
A questionnaire test (Beck depression Inventory) for depression was performed.
| Study group | Role | What they receive |
|---|---|---|
| Female Group | Other | Females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis) Receives: Other: Psychological measurements |
| Male Group | No intervention | males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression level
The differences in depression level between females and males. Depression level was determined using the Beck Depression Inventory.
Beck Depression Inventory (BDI) consists of 21 items. Each of the 21 statements is scored from 0 to 3. The total score allows the classification of depression severity. Scores less than 10 indicates lack of the depression. The scores between10-16 indicate minimum depression, the scores between17-29 indicate moderate depression, scores greater than 30 indicate severe depression.
Measured: Baseline
Secondary outcomes (4)
Probing pocket depth
Probing pocket depth (PPD) was measured for determining the severity of the disease and clinical outcome. High probing pocket depth shows more severe periodontal disease.
Measured: Baseline
Gingival index
The differences in gingival index scores between females and males. The gingival index was recorded for determining and classifying gingival status. The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
Measured: Baseline
Plaque index
The differences in plaque index scores between females and males. Plaque index (PI) was recorded for determining and classifying oral hygiene status. The Plaque Index (GI) scores each site on a 0 to 3 scale with 0 being no plaque in the gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: Baseline
Bleeding on probing
The differences in bleeding on probing scores between females and males. Bleeding on probing (BOP) has been used to diagnose the presence of periodontal diseases, and it is a reliable indicator of gingival inflammation. It is useful in providing either positive predictive values or negative predictive values that illustrate disease progression. A positive predictive value indicates the percentage of people who both exhibit BOP and are correctly diagnosed with progressive periodontal diseases. A negative predictive value indicates the percentage of people whose BOP test results show no bleeding and no active disease progression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start12 Feb 2017
- Primary completion12 Mar 2017
- Study completion12 Feb 2018
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.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uçan Yarkaç, Necmettin Erbakan University
- Investigators
- Fatma Ucan Yarkac, 1, Principal investigator, Necmettin Erbakan UniversityOzge Gokturk, 1, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682275
- Sponsor's protocol ID
- NecmettinCT
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
- ClinicalTrials.gov ID
- NCT04682275
- Acronym / sponsor ID
- NecmettinCT
- Conditions
- Periodontal Diseases, Depression, Gender, Gingival Diseases
- Keywords
- periodontal diseases, depression, gender, gingival diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 12 Feb 2017 (actual)
- Primary completion
- 12 Mar 2017 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 23 Dec 2020 (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.
There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.
Detailed description
Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.
Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female Group | Other | Other: Psychological measurementsFemales with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis) |
| Male Group | No intervention | –males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the presence of periodontal diseases
Key exclusion criteria (5 listed)
- the presence of any systemic disease other than depression
- smoking and alcohol consumption
- the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
- have received any periodontal treatment in the last six months
- hormonal condition such as pregnancy or lactation
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 |
|---|---|---|
| Psychological measurementsA questionnaire test (Beck depression Inventory) for depression was performed. | Other | Female Group |
Primary outcome
Depression level
Time frame: Baseline
The differences in depression level between females and males. Depression level was determined using the Beck Depression Inventory. Beck Depression Inventory (BDI) consists of 21 items. Each of the 21 statements is scored from 0 to 3. The total score allows the classification of depression severity. Scores less than 10 indicates lack of the depression. The scores between10-16 indicate minimum depression, the scores between17-29 indicate moderate depression, scores greater than 30 indicate severe depression.
4 secondary outcomes
Probing pocket depth
Time frame: Baseline
Gingival index
Time frame: Baseline
Plaque index
Time frame: Baseline
Bleeding on probing
Time frame: Baseline
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 24 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Fatma Ucan Yarkac, 1 principal investigator
Necmettin Erbakan University
Ozge Gokturk, 1 principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological measurements in people with Periodontal Diseases and Depression, run by Necmettin Erbakan 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 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 24 Dec 2020. 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?
Depression level (time frame: Baseline). 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 24 Dec 2020.