Periodontitis, Sleep Quality and Fatigue

NCT05622019 | Completed

• 1 other identifier: NecmettinEUperio
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

periodontal diseases; gingival health; sleep; fatigue; oral related quality of life

Outcome Measures

Primary Outcomes (4)

• Investigation of the relationship between periodontitis and sleep evaluating using Pittsburgh Sleep Quality Index (PSQI)

  The results obtained by comparing the total PSQI scores of the patients with the periodontal status of the patients constitute one of the primary results of this study.Scoring of the answers was based on a 0 to 3 scale. "5" or greater indicated a "poor" sleeper. Higher PSQI scores represented worse sleep quality.

  At the beginning of the study, PSQI was applied. This process was completed within 1 month.

• Investigation of the relationship between periodontitis and sleep evaluating using Jenkins sleep scale(JSS)

  The results obtained by comparing the total JSS scores of the patients with the periodontal status of the patients constitute one of the primary results of this study. Sleep disturbances are considered when the mean score is equal or greater than 2, corresponding to at least one troubled night per week

  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

• Investigation of the relationship between periodontitis and fatigue

  The results obtained by comparing the total Multidimensional Assessment of Fatigue scale (MAF) scores of the patients with the periodontal status of the patients constitute one of the primary results of this study. The index score can range from 1(no fatigue) to 50 (extreme fatigue). As the score obtained from the questionnaire increases, the level of fatigue increases.

  At the beginning of the study, Multidimensional Assessment of Fatigue scale (MAF) was applied. This process was completed within 1 month.

• Investigation of the relationship between periodontitis and oral health related quality of life (OHrQoL)

  OHRQoL was evaluated by using Oral Health Impact Profile-14 (OHIP-14). The results obtained by comparing the total OHIP-14 scores of the patients with the periodontal status of the patients constitute one of the primary results of this studyPatients answered their negative experiences on a 0 to 4 scale. The OHIP-14 score is the total score of the answers (0 to 56), with higher scores indicating poorer OHRQoL. Any score higher than the 14 was taken as an indication of poor OHRQoL

  At the beginning of the study, OHIP-14 questionnaire was applied. This process was completed within 1 month.

Secondary Outcomes (1)

• Comparison of data with periodontal status

  At the beginning of the study, Socia-demographic questionnaire was applied. This process was completed within 1 month.

Study Arms (2)

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

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, dentistry Faculty

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Fatigue

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 18, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 15, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

TU (1)