NCT04240015

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2014

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 17, 2020

Last Update Submit

January 22, 2020

Conditions

Periodontitis, Adult

Keywords

oral health related quality of lifeperiodontal disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes

Secondary Outcomes (1)

  • Complaints of study population.

    5 minutes

Study Arms (2)

Periodontitis

Periodontitis group consisted of patients diagnosed with periodontitis

Other: Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale

Patients without periodontitis

Patients without periodontitis group constituted patients without periodontitis

Other: Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale

Interventions

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.

Patients without periodontitisPeriodontitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients with 18 years and older
  • Patients have at least 20 remaining teeth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontal Diseases

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mehtap Bilgin Çetin

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 27, 2020

Study Start

October 5, 2013

Primary Completion

January 10, 2014

Study Completion

February 12, 2014

Last Updated

January 27, 2020

Record last verified: 2020-01