Clinical trial NCT05622019: Periodontitis, Sleep Quality and Fatigue
Official title: Evaluation of The Association Between Stage-Grade of Periodontitis and Sleep Quality and Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Sleep
Fatigue
Quality of Life
Healthy
Keywords: periodontal diseases
gingival health
sleep
fatigue
oral related quality of life
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 124
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: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This was a survey study reporting on a convenience sample of 124 healty subjects or patients with periodontitis reporting for care at the Periodontology Clinic, Necmettin Erbakan University. Konya.

Brief summary: The goal of this observational study is to investigate the association of stage-grade of periodontitis with sleep quality and fatigue and the effect of periodontitis on QoL (Quality of life) in individuals with periodontitis and gingivally healthy individuals.

The main questions it aims to answer are:

1. Have poor sleep quality, inadequate sleep and fatigue got an effect on periodontal status?
2. Has periodontal status got an effect on sleep quality and fatigue?
3. What is the effect of periodontal status on quality of life?

Routine clinical and radiographic periodontal examinations of the participants were performed. Groups were designed according to periodontal status and periodontitis-stages of participants. Group 1- Healthy; Group 2- Stage I periodontitis; Group 3- Stage II periodontitis; Group 4- Stage III periodontitis; Group 5- Stage IV periodontitis. The participants were only asked to fill out the questionnaires (socio-demographic survey, tooth cleaning habit survey, The Pittsburgh Sleep Quality Index(PSQI), The Jenkins Sleep Scale(JSS), Multidimensional Assessment of Fatigue scale (MAF) and Oral Health Impact Profile-14 (OHIP-14)) included in the study and were informed about them. Then, if necessary, the participants' routine periodontal treatments were performed.

In line with the findings of the study;

1. Sleep quality was found higher in gingival healthy individuals. 3. The severity of periodontitis increases, the sleep duration becomes shorter, 4. It has been observed that the sleep quality in terms of gender is lower in female individuals compared to male individuals.

Detailed description: This was a prospective survey study reporting on a convenience sample of 124 healthy subjects or patients with periodontitis reporting for care at the Periodontology Clinic, Necmettin Erbakan University. This study was approved by the Faculty of Dentistry Non-Pharmaceutical and Non-Medical Device Research Ethics Committee of Necmettin Erbakan University and was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. The study participants provided a written informed consent and comprehended the assessment details fully. The investigators excluded the participants who did not comprehend the questionnaire.

Before the study, the number of patients required for each group was determined by calculating the power (G \* Power 3.1 software; Heinrich Heine University, Düsseldorf, Germany). According to the power analysis results for one-way ANOVA test, the study performed on 5 groups provides 90% power and 0.37 effect size for a total of 115 samples. However, considering that there may be patients who could not continue the study, it was decided to include 124 people in the study.

Clinical measurements and stage diagnosis for all cases were performed by a single trained and calibrated investigator (KD) using Williams periodontal probes. Calibration exercise was performed in 10 non-study periodontitis patients. First, PD(probing pocket depth) and AL(attachment loss) were measured and the same protocol was repeated 1 hour later. Intra-examiner variabilities for PD and AL measurements were assessed after the completion of all measurements.

Statistical analyzes were performed with the SPSS (Statistical Package for the Social Sciences) 26.0 package program. The normality of the distribution was checked with the Kolmogorov Smirnov test. In the study, one-way anova test and Bonferroni test were used as post hoc test for comparison according to stage, grade, age and educational status, while independent sample t test was used for comparison according to gender. Pearson correlation analysis was applied to test the relationship between the scales. Chi-square analysis was used to evaluate the classification made according to sleep quality and the relationship between stage and grade. Chi-square analysis was used to evaluate the relationship between demographic characteristics and stage and grade. Statistical significance was assessed when p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years of age
* with no psychiatric, mental or physical disability
* those with no systemic diseases
* those with no medicine use, including antibiotics, during the previous 6 months
* without pregnancy and non-breastfeeding
* diagnosed as having healthy gingiva or periodontitis

Exclusion Criteria:

* not meet inclusion criteria
* fewer than 20 healthy teeth
* acute dental conditions that required urgent care such as an abscess, cellulitis, or diseases affecting the jawbones including cysts and neoplasms.
* history of periodontal therapy in the previous 6 months.

Primary outcomes:
measure: Investigation of the relationship between periodontitis and sleep evaluating using Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At the beginning of the study, PSQI was applied. This process was completed within 1 month.
measure: Investigation of the relationship between periodontitis and sleep evaluating using Jenkins sleep scale(JSS)
timeFrame: At the beginning of the study, JSS was applied. This process was completed within 1 month. Sleep disturbances are considered when the mean score is equal or greater than 2, corresponding to at least one troubled night per week
measure: Investigation of the relationship between periodontitis and fatigue
timeFrame: At the beginning of the study, Multidimensional Assessment of Fatigue scale (MAF) was applied. This process was completed within 1 month.
measure: Investigation of the relationship between periodontitis and oral health related quality of life (OHrQoL)
timeFrame: At the beginning of the study, OHIP-14 questionnaire was applied. This process was completed within 1 month.
Secondary outcomes:
measure: Comparison of data with periodontal status
timeFrame: At the beginning of the study, Socia-demographic questionnaire was applied. This process was completed within 1 month.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, dentistry Faculty
Study officials:
References: