Gum DiseaseNCT03190512
Periodontal Treatment and Psychology
A study testing Psychological measurements in people with Gum Disease, run by Ozge Gokturk 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 60 years
- Conditions the study is for
- Gum Disease
- What is being tested?
- Psychological measurements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2015to 1 Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the presence of periodontal diseases,
- the presence of diagnosed minor depression
- being under maintenance therapy regarding the depression
Who cannot join
- any hormonal condition such as pregnancy or lactation
- received any periodontal treatment within six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60250
About this study
Official title: The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial
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 multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.
Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.
- Conditions
- Gum Disease
- Being tested
- Psychological measurements
- Keywords
- Periodontal disease, depression, body image, self-esteem
- Medical subject headings
- Gingival Diseases, Periodontal Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological measurementsOther
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Psychological measurements were taken from periodontal disease patients before treatment and after 6 weeks.
Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and the Psychological questionnaires were filled. Receives: Other: Psychological measurements |
| Control Group | Placebo comparator | Psychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment.
Intervention: The Psychological questionnaires were filled. Receives: Other: Psychological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression level
The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.
Measured: Baseline and after 6 weeks
Secondary outcomes (8)
Body image level
The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.
Measured: Baseline and after 6 weeks
Anxiety level
The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.
Measured: Baseline and after 6 weeks
Self-esteem level
The changes in self-esteem level within 6 weeks. Self-esteem level was determined using the Rosenberg Self-Esteem Scale.
Measured: Baseline and after 6 weeks
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 after 6 weeks
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 after 6 weeks
Gingival index
The changes in gingival index level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Measured: Baseline and after 6 weeks
Plaque index
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Measured: Baseline and after 6 weeks
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 after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start4 May 2015
- Primary completion31 Mar 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozge Gokturk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ozge Gokturk, Tokat Gaziosmanpasa University
- Investigators
- Ozge Gokturk, Principal investigator, Gaziosmanpasa Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190512
- Sponsor's protocol ID
- 14-KAEK-218
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 16 Jun 2017
- 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 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03190512
- Acronym / sponsor ID
- 14-KAEK-218
- Conditions
- Gum Disease
- Keywords
- Periodontal disease, depression, body image, self-esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Ozge GokturkUniversity, hospital or other
- Study start
- 4 May 2015 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 16 Jun 2017 (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 multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.
Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Other: Psychological measurementsPsychological measurements were taken from periodontal disease patients before treatment and after 6 weeks. Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and the Psychological questionnaires were filled. |
| Control Group | Placebo comparator | Other: Psychological measurementsPsychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment. Intervention: The Psychological questionnaires were filled. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- the presence of periodontal diseases,
- the presence of diagnosed minor depression
- being under maintenance therapy regarding the depression
Key exclusion criteria (2 listed)
- any hormonal condition such as pregnancy or lactation
- received any periodontal treatment within six months
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 measurementsFour questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks. | Other | Control Group, Test Group |
Primary outcome
Depression level
Time frame: Baseline and after 6 weeks
The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.
8 secondary outcomes
Body image level
Time frame: Baseline and after 6 weeks
Anxiety level
Time frame: Baseline and after 6 weeks
Self-esteem level
Time frame: Baseline and after 6 weeks
Probing pocket depth
Time frame: Baseline and after 6 weeks
Clinical attachment level
Time frame: Baseline and after 6 weeks
Gingival index
Time frame: Baseline and after 6 weeks
Plaque index
Time frame: Baseline and after 6 weeks
Bleeding on probing
Time frame: Baseline and after 6 weeks
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 16 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Gum Disease
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
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
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.
Ozge Gokturk principal investigator
Gaziosmanpasa Universty
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 Gum Disease, run by Ozge Gokturk 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 3 inclusion and 2 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 16 Jun 2017. 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. 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.
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 and after 6 weeks). 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 16 Jun 2017.