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Oral Health Related Quality of Life and Periodontal Diseases

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ClinicalTrials.gov Identifier: NCT03549247
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
muge lutfioglu, Ondokuz Mayıs University

Brief 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 level against dentist and treatment.

Condition or disease Intervention/treatment
Periodontal Diseases Behavioral: quality of life in healthy,gingivitis,periodontitis groups

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
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.
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Group/Cohort Intervention/treatment
quality of life in periodontal healthy
250 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
Behavioral: quality of life in healthy,gingivitis,periodontitis groups
a questionnaire form evaluating oral hygiene habits and oral hygiene consciousness levels, OHIP-14 scale was applied

quality of life in gingivitis
250 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
Behavioral: quality of life in healthy,gingivitis,periodontitis groups
a questionnaire form evaluating oral hygiene habits and oral hygiene consciousness levels, OHIP-14 scale was applied

quality of life in periodontitis
250 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
Behavioral: quality of life in healthy,gingivitis,periodontitis groups
a questionnaire form evaluating oral hygiene habits and oral hygiene consciousness levels, OHIP-14 scale was applied




Primary Outcome Measures :
  1. OHIP score to evaluate the oral health related quality of life [ Time Frame: 1 day (on the day of examination) ]
    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.

  2. gingival index score for determining periodontal status [ Time Frame: 1 day (on the day of examination) ]
    the gingival index score (ranging 0 to 3) used to define the severity gingival inflammation in order to define the periodontal status.

  3. clinical attachment level measurement for determining periodontal status [ Time Frame: 1 day (on the day of examination) ]
    milimetric measurment of clinical attachement level by using periodontal probe to define the periodontal status.


Secondary Outcome Measures :
  1. ages [ Time Frame: 1 day (on the day of examination) ]
    Comparison of ages of healthy, gingivitis and periodontitis groups

  2. marital status [ Time Frame: 1 day(on the day of examination) ]
    Comparison of marital status of healthy, gingivitis and periodontitis groups

  3. education status [ Time Frame: 1 day(on the day of examination) ]
    Comparison of educational status of healthy, gingivitis and periodontitis groups detemined by the duration of education as years

  4. monthly income [ Time Frame: 1 day(on the day of examination) ]
    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.

  5. dental visit frequencies [ Time Frame: 1 day(on the day of examination) ]
    Comparison of dental visit frequencies of healthy, gingivitis and periodontitis groups by recording the frequency as when having complaints,sometimes and regularly.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
in our study Ondokuz Mayıs University Faculty of Dentistry Periodontology Clinic evaluated individuals who applied for control and treatment purposes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • don't be literate
  • have any systemic disease
  • use any medication
  • chemotherapy/ radiotherapy story
  • pregnancy or in lactation
  Study Documents (Full-Text)

Documents provided by muge lutfioglu, Ondokuz Mayıs University:
Study Protocol  [PDF] October 15, 2015


Additional Information:

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Responsible Party: muge lutfioglu, associate professor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT03549247     History of Changes
Other Study ID Numbers: OMU KAEK 2015/414
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by muge lutfioglu, Ondokuz Mayıs University:
OHIP-14
Periodontitis

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases