Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06129357 |
| Other study ID # |
DILEKÖZKANSEN |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2023 |
| Est. completion date |
November 20, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 Mediterranean diet and periodontal
status? Is there a relationship between physical activity and periodontal status?
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.
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