PeriodontitisNCT06129357
Evaluation of Nutritional Habits, Oral Hygiene, Relationship Between Dental Caries and Periodontal Condition
An observational study of Periodontitis and MEDİTERRANEAN DİET, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this observational study is to identify the dental and periodontal health issues, oral hygiene practices, and potential relationships between them by assessing the variables that may have an impact on them.The main questions its aims to answer are: Is there a relationship between compliance with the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, MEDİTERRANEAN DİET
- What is being tested?
- 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2023to 20 Nov 2023
- 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
- Adult, Older adult
Study population: Patients who visited the Necmettin Erbakan University Faculty of Dentistry Periodontology Clinic ,if they met the following criteria:
Who may be able to join
- Not having undergone dental scaling and root surface correction treatment in the last 6 months
- Presence of at least 20 teeth in the mouth
- Not pregnant and/or breastfeeding
- Patients taking drugs known to alter bone metabolism or no established degenerative bone diseases (hyperparathyroidism, osteoporosis)
- Patients who have not received antibiotics, nonsteroidal anti-inflammatory drugs, or corticosteroids for >2 weeks in the 3 months prior to the study.
Who cannot join
- Individuals who did not meet the inclusion criteria and did not agree to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi
Konya, Meram, 42050
About this study
Official title: Evaluation of Nutritional Habits, Oral Hygiene Status, Relationship Between Dental Caries and Periodontal Condition
The purpose of this observational study is to identify the dental and periodontal health issues, oral hygiene practices, and potential relationships between them by assessing the variables that may have an impact on them.The main questions its aims to answer are:
Is there a relationship between compliance with the Mediterranean diet and periodontal status? Is there a relationship between physical activity and periodontal status?
Read the detailed description
Patients who will visit the Periodontology Clinic will be consecutively enrolled in the study by one of the researchers (D.O.S), if they meet the following criteria:
- No smoking.
- Not having undergone dental scaling and root surface correction treatment in the last 6 months.
- Presence of at least 20 teeth in the mouth.
- Not pregnant and/or breastfeeding.
- Patients taking drugs known to alter bone metabolism or having established degenerative bone diseases (hyperparathyroidism, osteoporosis).
- Patients who have not received antibiotics, nonsteroidal anti-inflammatory drugs, or corticosteroids for >2 weeks in the 3 months prior to the study.
- Patients who agree to participate will undergo an oral examination and answer a questionnaire survey.
Periodontal Examination: Routine clinical periodontal parameters such as plaque index (PI), gingival index (GI), Probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment levels, and gingival recession will be recorded in all patient groups before treatment [13]. Individuals will be classified according to the 2017 classification [14].
After 30 seconds, at six locations per tooth, a calibrated clinical researcher will measure the probing depth (PD), which is the distance between the free gingival margin and the pocket depth, the clinical attachment level (CAL), which is the distance between the cement-enamel attachment and the pocket depth, and the bleeding on probing (BOP) [15]. According to the World Workshop on Classification and Conditions of Periodontal and Peri-implant Diseases 2017, periodontitis will be identified [14]. The PD severity index will be calculated as the percentage of teeth with PD higher than or equal to 4 mm in two or more interproximal locations [16]. Mean PD, CAL, and BoP will also be obtained. Additionally, the quantity of teeth will be recorded.
To the individuals included in the research; A questionnaire consisting of 16 questions including demographic data of individuals, the number of daily snacks, daily carbohydrate-containing food and sugary drink consumption frequency, tooth brushing frequency, and duration, education level, and oral care habits will be filled [17].
Dietary habits: assessed by the Mediterranean Diet Score (MDS) questionnaire and classified as low adherence (score ≤5), medium adherence (score 6-9), or high adherence (score ≥10) [18, 19].
Dental Examination: Number of decayed, missing, and filled teeth (DMFT) assessed by visual inspection and radiographic assessment following the International Caries Detection and Assessment System (ICDAS). All tooth surfaces will be examined, but the observations will be recorded per tooth [20].
Physical activity assessment: PA will be assessed through the validated short version of the International Physical Activity Questionnaire (IPAQ)[21]. The IPAQ automatic report will categorize the total PA level as low, moderate, or high (https: //theipaq/home).
2.5 Statistical analysis Using IBM SPSS V23, the data will be examined. The Kolmogorov-Smirnov and Shapiro-Wilk tests will be used to gauge conformity to the normal distribution. Multiple comparisons will be examined using the Bonferroni Corrected Z Test, and categorical variables will be examined using the Pearson Chi-Square Test. To compare the parameters with the normal distribution according to the groups, a one-way analysis of variance will be utilized. The parameters that do not meet the normal distribution according to the groups will be compared using the Kruskal-Wallis test and multiple comparisons using the Dunn test. For categorical variables, the analysis findings will be shown as frequency (%), whereas for quantitative variables, the results will be shown as mean, standard deviation, and median (minimum to maximum). P 0.050 will be used as the significance level. The risk factors affecting the disease will be examined by Binary Logistic Regression Analysis, and the Enter method will be used to include the variables in the model. Analysis results will be presented as frequency (percentage) for categorical variables and as mean ± standard deviation for quantitative variables. The significance level will be taken as p<0.050.
- Conditions
- Periodontitis, MEDİTERRANEAN DİET
- Being tested
- 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).Behavioural
Diagnostic Test: Full periodontal chart A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of gingivitis | 60 Receives: Behavioral: 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60). | |
| Diagnosed as periodontal healthys | 60 Receives: Behavioral: 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60). | |
| Diagnosis of periodontitis | 60 Receives: Behavioral: 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60). |
What is being measured
The primary outcome is the main question the study is designed to answer.
INVESTIGATION OF THE RELATIONSHIP BETWEEN PERIODONTAL DISEASE AND ADAPTION TO THE MEDITERRANEAN DIET.
Dietary habits: Assessed by the Mediterranean Diet Score (MDS) questionnaire and will be classified as low adherence (score ≤5), medium adherence (score 6-9) or high adherence (score ≥10). Its effect on periodontal status will be determined.
Measured: BASELİNE
INVESTIGATION OF THE RELATIONSHIP BETWEEN PERIODONTAL DISEASE AND ADAPTION TO THE PHYSİCAL ACTİVİTY
Physical activity assessment: PA will be assessed through the validated short version of the International Physical Activity Questionnaire (IPAQ). The IPAQ automatic report will classify the total PA level into low, medium and high.A high score means high physical activity.
Measured: BASELİNE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start2 Feb 2023
- Primary completion15 May 2023
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Özkan Şen, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129357
- Sponsor's protocol ID
- DİLEKÖZKANŞEN
- Status last verified
- Nov 2023
- First submitted
- 30 May 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Habits, Oral Hygiene Status, Relationship Between Dental Caries and Periodontal Condition
- ClinicalTrials.gov ID
- NCT06129357
- Acronym / sponsor ID
- DİLEKÖZKANŞEN
- Conditions
- Periodontitis, MEDİTERRANEAN DİET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 13 Nov 2023 (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 purpose of this observational study is to identify the dental and periodontal health issues, oral hygiene practices, and potential relationships between them by assessing the variables that may have an impact on them.The main questions its aims to answer are:
Is there a relationship between compliance with the Mediterranean diet and periodontal status? Is there a relationship between physical activity and periodontal status?
Detailed description
Patients who will visit the Periodontology Clinic will be consecutively enrolled in the study by one of the researchers (D.O.S), if they meet the following criteria:
- No smoking.
- Not having undergone dental scaling and root surface correction treatment in the last 6 months.
- Presence of at least 20 teeth in the mouth.
- Not pregnant and/or breastfeeding.
- Patients taking drugs known to alter bone metabolism or having established degenerative bone diseases (hyperparathyroidism, osteoporosis).
- Patients who have not received antibiotics, nonsteroidal anti-inflammatory drugs, or corticosteroids for >2 weeks in the 3 months prior to the study.
- Patients who agree to participate will undergo an oral examination and answer a questionnaire survey.
Periodontal Examination: Routine clinical periodontal parameters such as plaque index (PI), gingival index (GI), Probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment levels, and gingival recession will be recorded in all patient groups before treatment [13]. Individuals will be classified according to the 2017 classification [14].
After 30 seconds, at six locations per tooth, a calibrated clinical researcher will measure the probing depth (PD), which is the distance between the free gingival margin and the pocket depth, the clinical attachment level (CAL), which is the distance between the cement-enamel attachment and the pocket depth, and the bleeding on probing (BOP) [15]. According to the World Workshop on Classification and Conditions of Periodontal and Peri-implant Diseases 2017, periodontitis will be identified [14]. The PD severity index will be calculated as the percentage of teeth with PD higher than or equal to 4 mm in two or more interproximal locations [16]. Mean PD, CAL, and BoP will also be obtained. Additionally, the quantity of teeth will be recorded.
To the individuals included in the research; A questionnaire consisting of 16 questions including demographic data of individuals, the number of daily snacks, daily carbohydrate-containing food and sugary drink consumption frequency, tooth brushing frequency, and duration, education level, and oral care habits will be filled [17].
Dietary habits: assessed by the Mediterranean Diet Score (MDS) questionnaire and classified as low adherence (score ≤5), medium adherence (score 6-9), or high adherence (score ≥10) [18, 19].
Dental Examination: Number of decayed, missing, and filled teeth (DMFT) assessed by visual inspection and radiographic assessment following the International Caries Detection and Assessment System (ICDAS). All tooth surfaces will be examined, but the observations will be recorded per tooth [20].
Physical activity assessment: PA will be assessed through the validated short version of the International Physical Activity Questionnaire (IPAQ)[21]. The IPAQ automatic report will categorize the total PA level as low, moderate, or high (https: //theipaq/home).
2.5 Statistical analysis Using IBM SPSS V23, the data will be examined. The Kolmogorov-Smirnov and Shapiro-Wilk tests will be used to gauge conformity to the normal distribution. Multiple comparisons will be examined using the Bonferroni Corrected Z Test, and categorical variables will be examined using the Pearson Chi-Square Test. To compare the parameters with the normal distribution according to the groups, a one-way analysis of variance will be utilized. The parameters that do not meet the normal distribution according to the groups will be compared using the Kruskal-Wallis test and multiple comparisons using the Dunn test. For categorical variables, the analysis findings will be shown as frequency (%), whereas for quantitative variables, the results will be shown as mean, standard deviation, and median (minimum to maximum). P 0.050 will be used as the significance level. The risk factors affecting the disease will be examined by Binary Logistic Regression Analysis, and the Enter method will be used to include the variables in the model. Analysis results will be presented as frequency (percentage) for categorical variables and as mean ± standard deviation for quantitative variables. The significance level will be taken as p<0.050.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of gingivitis | – | Behavioral: 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).60 |
| Diagnosed as periodontal healthys | – | Behavioral: 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).60 |
| Diagnosis of periodontitis | – | Behavioral: 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).60 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the Necmettin Erbakan University Faculty of Dentistry Periodontology Clinic ,if they met the following criteria:
Key inclusion criteria (5 listed)
- Not having undergone dental scaling and root surface correction treatment in the last 6 months
- Presence of at least 20 teeth in the mouth
- Not pregnant and/or breastfeeding
- Patients taking drugs known to alter bone metabolism or no established degenerative bone diseases (hyperparathyroidism, osteoporosis)
- Patients who have not received antibiotics, nonsteroidal anti-inflammatory drugs, or corticosteroids for >2 weeks in the 3 months prior to the study.
Key exclusion criteria (1 listed)
- Individuals who did not meet the inclusion criteria and did not agree to participate in the study were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 180 individuals who applied to the Periodontology Clinic were included in the study. Individuals were divided into 3 groups as healthy (n=60), gingivitis (n=60) and periodontitis (n=60).Diagnostic Test: Full periodontal chart A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases. | Behavioural | Diagnosed as periodontal healthys, Diagnosis of gingivitis, Diagnosis of periodontitis |
Primary outcome
INVESTIGATION OF THE RELATIONSHIP BETWEEN PERIODONTAL DISEASE AND ADAPTION TO THE MEDITERRANEAN DIET.
Time frame: BASELİNE
Dietary habits: Assessed by the Mediterranean Diet Score (MDS) questionnaire and will be classified as low adherence (score ≤5), medium adherence (score 6-9) or high adherence (score ≥10). Its effect on periodontal status will be determined.
INVESTIGATION OF THE RELATIONSHIP BETWEEN PERIODONTAL DISEASE AND ADAPTION TO THE PHYSİCAL ACTİVİTY
Time frame: BASELİNE
Physical activity assessment: PA will be assessed through the validated short version of the International Physical Activity Questionnaire (IPAQ). The IPAQ automatic report will classify the total PA level into low, medium and high.A high score means high physical activity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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 Periodontitis and MEDİTERRANEAN DİET, 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
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 PERIODONTAL DISEASE AND ADAPTION TO THE MEDITERRANEAN DIET. (time frame: BASELİNE). The study lists 2 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 13 Nov 2023.