Periodontal DiseasesNCT05622019
Periodontitis, Sleep Quality and Fatigue
An observational study of Periodontal Diseases and Sleep, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Sleep, Fatigue
- Type of treatment
- Pill or oral medicine
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, dentistry Faculty
Konya
About this study
Official title: Evaluation of The Association Between Stage-Grade of Periodontitis and Sleep Quality and Fatigue
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:
Read more
- Have poor sleep quality, inadequate sleep and fatigue got an effect on periodontal status?
- Has periodontal status got an effect on sleep quality and fatigue?
- 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;
- 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.
Read the 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
- Keywords
- periodontal diseases, gingival health, sleep, fatigue, oral related quality of life
- Medical subject headings
- Periodontal Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Each enrolled participant was asked to complete a questionnaire. The questionnaire consisted of the following three main parts: (i) demographic characteristics (age, educational attainment); and (ii)tooth-cleaning habits. The results of the comparison of these data with the periodontal situation constitute the secondary result of the study.
Measured: At the beginning of the study, Socia-demographic questionnaire was applied. This process was completed within 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Tastan Eroglu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622019
- Sponsor's protocol ID
- NecmettinEUperio
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Association Between Stage-Grade of Periodontitis and Sleep Quality and Fatigue
- ClinicalTrials.gov ID
- NCT05622019
- Acronym / sponsor ID
- NecmettinEUperio
- Conditions
- Periodontal Diseases, Sleep, Fatigue, Quality of Life, Healthy
- Keywords
- periodontal diseases, gingival health, sleep, fatigue, oral related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Have poor sleep quality, inadequate sleep and fatigue got an effect on periodontal status?
- Has periodontal status got an effect on sleep quality and fatigue?
- 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;
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigation of the relationship between periodontitis and sleep evaluating using Pittsburgh Sleep Quality Index (PSQI)
Time frame: At the beginning of the study, PSQI was applied. This process was completed within 1 month.
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.
Investigation of the relationship between periodontitis and sleep evaluating using Jenkins sleep scale(JSS)
Time frame: 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
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
Investigation of the relationship between periodontitis and fatigue
Time frame: At the beginning of the study, Multidimensional Assessment of Fatigue scale (MAF) was applied. This process was completed within 1 month.
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.
Investigation of the relationship between periodontitis and oral health related quality of life (OHrQoL)
Time frame: At the beginning of the study, OHIP-14 questionnaire was applied. This process was completed within 1 month.
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
1 secondary outcome
Comparison of data with periodontal status
Time frame: At the beginning of the study, Socia-demographic questionnaire was applied. This process was completed within 1 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Sleep, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the relationship between periodontitis and sleep evaluating using Pittsburgh Sleep Quality Index (PSQI) (time frame: At the beginning of the study, PSQI was applied. This process was completed within 1 month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.