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Periodontal DiseasesNCT03549247

Oral Health Related Quality of Life and Periodontal Diseases

An observational study of Periodontal Diseases, run by Ondokuz Mayıs University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study was to evaluate the periodontal healthy and diseased individuals with questionnaire, 0ral health impact profile-14(OHIP-14) and dental hygiene fear scale (DHFS) scales and to examine the effect of periodontal disease on the quality of life in relation to oral health consciousness level and fear… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
quality of life in healthy,gingivitis,periodontitis groups
How many people
750 participants
Where
No sites listed yet
Study dates
11 Nov 2015to 27 Oct 2017
How long will I take part?
1 Day
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: in our study Ondokuz Mayıs University Faculty of Dentistry Periodontology Clinic evaluated individuals who applied for control and treatment purposes

Who may be able to join

  • be literate
  • systemic healthy
  • do not use medication for any reason
  • no chemotherapy / radiotherapy story
  • not pregnant or in lactation

Who cannot join

  • don't be literate
  • have any systemic disease
  • use any medication
  • chemotherapy/ radiotherapy story
  • pregnancy or in lactation

About this study

Official title: Evaluation of the Effect of Periodontal Status and Oral Health Consciousness Level on Oral Health Quality of Life by Using OHIP-14 Scale.

The aim of our study was to evaluate the periodontal healthy and diseased individuals with questionnaire, 0ral health impact profile-14(OHIP-14) and dental hygiene fear scale (DHFS) scales and to examine the effect of periodontal disease on the quality of life in relation to oral health consciousness level and fear level against dentist and treatment.

Read the detailed description

In clinical practice, assessments may provide to detect the disease effected oral sites and the extend of the disease by determining 'objective' surrogate markers but in generally patient based 'subjective' outcomes of those surrogate markers is not evaluated . Oral Health Impact Profile-14 (OHIP-14) is a kind of measurement that is designed to provide a comprehensive detection of the dysfunction,discomfort and disability attributed to oral conditions. Although there are some researchers who have investigated the relationships between patient perceptions and periodontal disease and treatment, further studies are needed to produce more reliable outcomes. It is also well known that psychological and socio demographic status strongly affect the quality of life and these basic key factors of life were also modify the periodontal status of individuals. However, the psychological and socio demographic factors over looked in many of the previous studies,large scale group studies with the survey of quality of life and periodontal status screening are not sufficient. Therefore, the aim of this study was to evaluate the patients with different periodontal status with OHIP-14 scale and a questionnaire to detect the oral health consciousness level.

The protocol of this randomized controlled clinical survey study was approved by the Ethical Committee of the Faculty of Dentistry, ondokuz mayıs university, Turkey, and the study was conducted in accordance with the Declaration of Helsinki. Informed written consent was obtained from all subjects after the details of the clinical procedures were explained. Systematically healthy 750 individuals (subject) aged ≥18 years that referred to the Department of Periodontology, Faculty of Dentistry, ondokuz mayıs University, either for dental treatment or only for dental check-up were included in the study. Prior to dental examination the questionnaire form to detect oral hygiene habits and oral hygiene consciousness levels and the OHIP-14 form to evaluate impact of periodontal status on quality of life were applied to each participants.

Periodontal disease status was determined according to clinical and radiographic criteria. In order to determine the periodontal status of the plaque index(PI), gingival index(GI), probing pocket depth(PPD) and clinical attachment level(CAL) were recorded. Study participants were distributed into three groups as periodontally healthy(H; n=250), gingivitis (G; n=250)and chronic periodontitis (CP; n=250). The relationship between periodontal status with quality of life and perception of how oral health influences the quality of life as well as percieved oral health and oral hygiene consciousness level were evaluted.

Demograhic assesments:

The age, sex, years of education, monthly income, smoking status, oral hygiene habitsvof each participant was recorded.

Assessment of OHIP:

The relationship between periodontal status with quality of life is evaluated with OHIP-14 scale. The validity and reliability of OHIP, consisting of 49 questions, was made by Slade and Spencer . The short form of OHIP was developed due to answering and scoring scales can take a long time and the validity and reliability of OHIP-14 is confirmed by Slade (Slade, 1997). The answers are scored according to the Likert scale. Responses to the items were recorded on a six-point scale: never=0,seldom=1, sometimes=2, fairly often=3, very often=4 and all time=5. The high scores revealed the adversely affected quality of life. The participants were informed on how to complete the indexes. Cronbach's alpha value, which indicates the internal consistency of the scale, is 0.94. The reliability and validity of the Turkish version of the OHIP-14 scale was determined by Mumcu et al. (2006) report.

Assesment of percieved oral health and oral hygiene consciousness level:

The patient based explanation of the periodontal status and the conciousness level and application of oral hygiene measures were detected by applying a questionnaire form.

Being tested
quality of life in healthy,gingivitis,periodontitis groups
Keywords
OHIP-14, Periodontitis
Medical subject headings
Periodontal Diseases, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality of life in healthy,gingivitis,periodontitis groupsBehavioural

    a questionnaire form evaluating oral hygiene habits and oral hygiene consciousness levels, OHIP-14 scale was applied

Study groups in NCT03549247
Study groupRoleWhat they receive
quality of life in periodontal healthy250 individuals who have teeth pocket depth is at most 3 mm and there is no loss of attachment, no radiological bone loss and no gingival inflammation determeined for their quality of life
Receives: Behavioral: quality of life in healthy,gingivitis,periodontitis groups
quality of life in gingivitis250 individuals who have teeth pocket depth in the mouth is at most 3 mm and there is no loss of attachment, no radiological bone loss and have chronic gingival inflammation with the sign of bleeding determeined for their quality of life
Receives: Behavioral: quality of life in healthy,gingivitis,periodontitis groups
quality of life in periodontitis250 individuals who have more than 30% of teeth in the mouth which have pocket depths equal or more than 4mm and clinical attachment levels equal or more than 5mm and have radiologically detected bone loss determeined for their quality of life
Receives: Behavioral: quality of life in healthy,gingivitis,periodontitis groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OHIP score to evaluate the oral health related quality of life

    The changes in OHIP-14 scores (ranging between 0 to 56) determined by the questionnaire applied to the study groups. This questionnare reflected the quality of of life of individual that has oral health problem and the high scores revealed the adversely affected quality of life.

    Measured: 1 day (on the day of examination)

  2. gingival index score for determining periodontal status

    the gingival index score (ranging 0 to 3) used to define the severity gingival inflammation in order to define the periodontal status.

    Measured: 1 day (on the day of examination)

  3. clinical attachment level measurement for determining periodontal status

    milimetric measurment of clinical attachement level by using periodontal probe to define the periodontal status.

    Measured: 1 day (on the day of examination)

Secondary outcomes (5)
  1. ages

    Comparison of ages of healthy, gingivitis and periodontitis groups

    Measured: 1 day (on the day of examination)

  2. marital status

    Comparison of marital status of healthy, gingivitis and periodontitis groups

    Measured: 1 day(on the day of examination)

  3. education status

    Comparison of educational status of healthy, gingivitis and periodontitis groups detemined by the duration of education as years

    Measured: 1 day(on the day of examination)

  4. monthly income

    Comparison of the monthly income of healthy, gingivitis and periodontitis groups detremined by recording the participants as Less than minimum wage, minimum wage, more than minimum wage.

    Measured: 1 day(on the day of examination)

  5. dental visit frequencies

    Comparison of dental visit frequencies of healthy, gingivitis and periodontitis groups by recording the frequency as when having complaints,sometimes and regularly.

    Measured: 1 day(on the day of examination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start11 Nov 2015
  3. Primary completion30 Jul 2017
  4. Study completion27 Oct 2017

Resources

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
750 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03549247
Sponsor's protocol ID
OMU KAEK 2015/414
Status last verified
Jun 2018
First submitted
5 Apr 2018
Last updated
7 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Besiroglu E, Lutfioglu M. Relations between periodontal status, oral health-related quality of life and perceived oral health and oral health consciousness levels in a Turkish population. Int J Dent Hyg. 2020 Aug;18(3):251-260. doi: 10.1111/idh.12443. Epub 2020 May 20.

    PubMed 32367616

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases, run by Ondokuz Mayıs 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 5 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 7 Jun 2018. 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?

OHIP score to evaluate the oral health related quality of life (time frame: 1 day (on the day of examination)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03549247, which also lists 1 linked publication.

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 7 Jun 2018.

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