Periodontitis, AdultNCT04240015
Association of Periodontitis With Oral Health Related Quality of Life
An observational study of Periodontitis, Adult, run by Baskent University.
Trial summary
Objective: The aim of this study was to investigate the impact of periodontitis on oral health-related quality of life (OHQoL) and the factors may associated with OHQoL. Methods: 50 untreated periodontitis patients and 50 individuals without periodontitis were enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2013to 12 Feb 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The present clinical study was conducted with a study group of 50 untreated periodontitis patients and a control group of 50 individuals without periodontitis (age and gender matched) who applied to Hacettepe University Faculty of Dentistry Department of Periodontology.
Who may be able to join
- Patients with 18 years and older
- Patients have at least 20 remaining teeth
Who cannot join
- Individuals who have received periodontal treatment in the last 6 months individuals (anti-inflammatory, antibiotic, etc.)
- Pregnancy
- Subjects with systemic disease and who used any medication that may affect the periodontal condition in the last 6 months
About this study
Objective: The aim of this study was to investigate the impact of periodontitis on oral health-related quality of life (OHQoL) and the factors may associated with OHQoL.
Methods: 50 untreated periodontitis patients and 50 individuals without periodontitis were enrolled in the study. All subjects underwent detailed periodontal examination and probing depth (PD), clinical attachment level (CAL) measurements were performed. OHRQoL was assessed through the Oral Health Quality of Life-United Kingdom (OHRQoL-UK) scale. Symptoms of periodontitis was determined by Visual Analogue Scale (VAS). Socio-demographic characteristics, medical history, smoking status, hygiene habits of the all individuals were recorded.
Read the detailed description
The primary aim of the present study was to compare the scores of OHQoL-UK of patients with periodontitis to who didn't have periodontitis/healthy controls. Our second aim was investigate the factors (education, smoking, gender, periodontal clinical parameters) may related to oral health related quality of life).
Materials and methods Study group The present clinical study was conducted with a study group of 50 untreated periodontitis patients and a control group of 50 individuals without periodontitis (age and gender matched) who applied to Hacettepe University Faculty of Dentistry Department of Periodontology. Clinical examination and evaluation of patients' complaint All participants underwent comprehensive periodontal examination by a calibrated and masked examiner. probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket) and clinical attachment level (CAL = distance between the cement-enamel junction and bottom of the periodontal pocket) were evaluated. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar.The patients' complaints/symptoms associated with periodontitis (gingival bleeding and edema, halitosis, flaring, mobile teeth, gingival hyperemia, bad taste, dentin/root sensitivity) were also evaluated by using Visual Analogue Scale [VAS (0-10)]. In the evaluation with VAS, a straight line of 100 mm was used on the vertical axis and the starting and ending points were numbered 0 and 100. Individuals were asked to what extent they perceived the symptoms of periodontitis and were asked to make an evaluation between 0 and 100 on the scale and to put an x mark on the scale. In the evaluation of the scale, the marking point of the patient was measured with a caliper from the beginning of the scale.
Assesment of OHRQoL OHRQoL was assessed using the Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale. It consists of 4 different categories and 16 questions evaluating the effects of OHRQoL in positive and negative areas. These categories are as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores obtained from all questions were summed to give the scores of the 4 sub-categories separately and the total OHRQoL score. A higher total score indicates a higher OHRQoL.
- Conditions
- Periodontitis, Adult
- Being tested
- Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale
- Keywords
- oral health related quality of life, periodontal disease
- Medical subject headings
- Chronic Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scaleOther
It consists of 4 different categories and 16 questions evaluating the effects of OHRQoL in positive and negative areas. These categories are as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores obtained from all questions were summed to give the scores of the 4 sub-categories separately and the total OHRQoL score. A higher total score indicates a higher OHRQoL.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Periodontitis group consisted of patients diagnosed with periodontitis Receives: Other: Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale | |
| Patients without periodontitis | Patients without periodontitis group constituted patients without periodontitis Receives: Other: Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHRQoL-UK scores of the study population
OHRQoL was assessed using the Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale.It consists of 4 different categories and 16 questions that evaluate the effects of OHRQoL in both positive and negative areas. These categories are listed as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores were gathered from all surveys and they were summarized to give the scores of 4 sub-categories separately, along with the total OHRQoL score. A higher total score indicates a higher OHRQoL.
Measured: 20 minutes
Secondary outcomes (1)
Complaints of study population.
Patient complaints and symptoms associated with periodontitis, which is characterized by gingival bleeding and edema, halitosis, flaring, mobile teeth, gingival hyperemia, bad taste and dentin/root sensitivity, were also evaluated using Visual Analogue Scale [VAS (0-10)]. In VAS evaluation, a straight line of 100 mm was used on the vertical axis and the starting and ending points were numbered as 0 and 100. Individuals were asked to assess to what extent they perceived the symptoms of periodontitis. They were requested to make an evaluation between 0 and 100 scale and mark that scale. Patient's score was measured with a caliper from the beginning of the scale.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start5 Oct 2013
- Primary completion10 Jan 2014
- Study completion12 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Bilgin Çetin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240015
- Sponsor's protocol ID
- Mehtap
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Periodontitis With Oral Health Related Quality of Life
- ClinicalTrials.gov ID
- NCT04240015
- Acronym / sponsor ID
- Mehtap
- Conditions
- Periodontitis, Adult
- Keywords
- oral health related quality of life, periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 5 Oct 2013
- Primary completion
- 10 Jan 2014 (actual)
- Study completion
- 12 Feb 2014 (actual)
- First posted
- 27 Jan 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.
Objective: The aim of this study was to investigate the impact of periodontitis on oral health-related quality of life (OHQoL) and the factors may associated with OHQoL.
Methods: 50 untreated periodontitis patients and 50 individuals without periodontitis were enrolled in the study. All subjects underwent detailed periodontal examination and probing depth (PD), clinical attachment level (CAL) measurements were performed. OHRQoL was assessed through the Oral Health Quality of Life-United Kingdom (OHRQoL-UK) scale. Symptoms of periodontitis was determined by Visual Analogue Scale (VAS). Socio-demographic characteristics, medical history, smoking status, hygiene habits of the all individuals were recorded.
Detailed description
The primary aim of the present study was to compare the scores of OHQoL-UK of patients with periodontitis to who didn't have periodontitis/healthy controls. Our second aim was investigate the factors (education, smoking, gender, periodontal clinical parameters) may related to oral health related quality of life).
Materials and methods Study group The present clinical study was conducted with a study group of 50 untreated periodontitis patients and a control group of 50 individuals without periodontitis (age and gender matched) who applied to Hacettepe University Faculty of Dentistry Department of Periodontology. Clinical examination and evaluation of patients' complaint All participants underwent comprehensive periodontal examination by a calibrated and masked examiner. probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket) and clinical attachment level (CAL = distance between the cement-enamel junction and bottom of the periodontal pocket) were evaluated. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar.The patients' complaints/symptoms associated with periodontitis (gingival bleeding and edema, halitosis, flaring, mobile teeth, gingival hyperemia, bad taste, dentin/root sensitivity) were also evaluated by using Visual Analogue Scale [VAS (0-10)]. In the evaluation with VAS, a straight line of 100 mm was used on the vertical axis and the starting and ending points were numbered 0 and 100. Individuals were asked to what extent they perceived the symptoms of periodontitis and were asked to make an evaluation between 0 and 100 on the scale and to put an x mark on the scale. In the evaluation of the scale, the marking point of the patient was measured with a caliper from the beginning of the scale.
Assesment of OHRQoL OHRQoL was assessed using the Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale. It consists of 4 different categories and 16 questions evaluating the effects of OHRQoL in positive and negative areas. These categories are as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores obtained from all questions were summed to give the scores of the 4 sub-categories separately and the total OHRQoL score. A higher total score indicates a higher OHRQoL.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | Other: Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scalePeriodontitis group consisted of patients diagnosed with periodontitis |
| Patients without periodontitis | – | Other: Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scalePatients without periodontitis group constituted patients without periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The present clinical study was conducted with a study group of 50 untreated periodontitis patients and a control group of 50 individuals without periodontitis (age and gender matched) who applied to Hacettepe University Faculty of Dentistry Department of Periodontology.
Key inclusion criteria (2 listed)
- Patients with 18 years and older
- Patients have at least 20 remaining teeth
Key exclusion criteria (3 listed)
- Individuals who have received periodontal treatment in the last 6 months individuals (anti-inflammatory, antibiotic, etc.)
- Pregnancy
- Subjects with systemic disease and who used any medication that may affect the periodontal condition in the last 6 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 |
|---|---|---|
| Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scaleIt consists of 4 different categories and 16 questions evaluating the effects of OHRQoL in positive and negative areas. These categories are as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores obtained from all questions were summed to give the scores of the 4 sub-categories separately and the total OHRQoL score. A higher total score indicates a higher OHRQoL. | Other | Patients without periodontitis, Periodontitis |
Primary outcome
OHRQoL-UK scores of the study population
Time frame: 20 minutes
OHRQoL was assessed using the Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale.It consists of 4 different categories and 16 questions that evaluate the effects of OHRQoL in both positive and negative areas. These categories are listed as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores were gathered from all surveys and they were summarized to give the scores of 4 sub-categories separately, along with the total OHRQoL score. A higher total score indicates a higher OHRQoL.
1 secondary outcome
Complaints of study population.
Time frame: 5 minutes
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 27 Jan 2020.
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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?
An observational study of Periodontitis, Adult, run by Baskent University.
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 2 inclusion and 3 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 27 Jan 2020. 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. 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?
OHRQoL-UK scores of the study population (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 27 Jan 2020.