Periodontitis, Sleep Quality and Fatigue

NCT ID: NCT05622019

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-06-15

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.

Conditions

Periodontal Diseases; Sleep; Fatigue; Quality of Life; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Gingival health

Healthy participants had no sites with inter-proximal attachment loss, probing pocket depth (PPD) of ≤3 mm in all sites, bleeding on probing (BOP) ≤ 10%, and had \<10% of sites with modified gingival index (mGI) ≥ 2

No interventions assigned to this group

periodontitis

Participants were diagnosed with periodontitis if interdental clinical attachment loss (AL) was detected at ≥2 non-adjacent teeth, or buccal or oral AL was ≥3 mm with probing depth ≥3 mm was detected at ≥2 teeth.The participants in this group were divided into subgroups according to their periodontitis stage grade.

No interventions assigned to this group

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Tastan Eroglu

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Necmettin Erbakan University, dentistry Faculty

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NecmettinEUperio

Identifier Type: -

Identifier Source: org_study_id