NCT03549247

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

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

November 11, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

April 5, 2018

Last Update Submit

June 6, 2018

Conditions

Keywords

OHIP-14Periodontitis

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 day (on the day of examination)

  • 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.

    1 day (on the day of examination)

  • clinical attachment level measurement for determining periodontal status

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

    1 day (on the day of examination)

Secondary Outcomes (5)

  • ages

    1 day (on the day of examination)

  • marital status

    1 day(on the day of examination)

  • education status

    1 day(on the day of examination)

  • monthly income

    1 day(on the day of examination)

  • dental visit frequencies

    1 day(on the day of examination)

Study Arms (3)

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

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

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

Interventions

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

quality of life in gingivitisquality of life in periodontal healthyquality of life in periodontitis

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 5, 2018

First Posted

June 7, 2018

Study Start

November 11, 2015

Primary Completion

July 30, 2017

Study Completion

October 27, 2017

Last Updated

June 7, 2018

Record last verified: 2018-06