Clinical trial NCT03549247: Oral Health Related Quality of Life and Periodontal Diseases
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: OHIP-14
Periodontitis
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility 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

Primary outcomes:
measure: OHIP score to evaluate the oral health related quality of life
timeFrame: 1 day (on the day of examination)
measure: gingival index score for determining periodontal status
timeFrame: 1 day (on the day of examination)
measure: clinical attachment level measurement for determining periodontal status
timeFrame: 1 day (on the day of examination)
Secondary outcomes:
measure: ages
timeFrame: 1 day (on the day of examination)
measure: marital status
timeFrame: 1 day(on the day of examination)
measure: education status
timeFrame: 1 day(on the day of examination)
measure: monthly income
timeFrame: 1 day(on the day of examination)
measure: dental visit frequencies
timeFrame: 1 day(on the day of examination)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.