Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130189
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-11-07
Brief Title:
Nutrition Physical Activity Mediterranean Diet Adherence and Childrens Oral Health
Sponsor:
Ankara Medipol University
Organization:
Ankara Medipol University
Study Overview
Official Title:
The Impact of Nutrition Physical Activity Habits and Adherence to the Mediterranean Diet on Childrens Oral Health
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main risk factors for dental caries are inadequate oral hygiene practices cariogenic bacteria and cariogenic diet Among these factors diet has a different dual relationship with dental caries Dietary habits have the potential to be a risk factor for dental caries impaired oral and dental health can also lead to deficiencies in dietary intake
Studies have shown that there is a decrease in gum and periodontal diseases in the adult age group with a diet compatible with the Mediterranean diet
This cross-sectional study aims to examine the relationship between a diet compatible with the Mediterranean Diet and dental caries and gum health status in children We hypothesize that children will have better gum health and less tooth decay with a diet compatible with the Mediterranean diet
Studies have shown that there is a decrease in gum and periodontal diseases in the adult age group with a diet compatible with the Mediterranean diet
This cross-sectional study aims to examine the relationship between a diet compatible with the Mediterranean Diet and dental caries and gum health status in children We hypothesize that children will have better gum health and less tooth decay with a diet compatible with the Mediterranean diet
Detailed Description:
Aim and Importance of the Research
The Mediterranean diet AD is a healthy nutritional model and the risk of major chronic inflammatory diseases decreases with a diet highly compatible with MD It is thought that the protective effect of the Mediterranean diet is related to unsaturated fatty acids the amount of dietary fiber bioactive components and antioxidants It is known that diet affects the inflammatory reaction of periodontal tissues It is stated that inflammatory reactions in the gums cannot develop especially with a diet that does not contain refined carbohydrates It is reported in the literature that reducing carbohydrate intake and taking additional Omega-3 fatty acids vitamin C vitamin D antioxidants and fiber is beneficial for the health of periodontal tissues
While excessive carbohydrate intake increases dysbiosis and chronic inflammatory diseases a decrease in gingivitis has been observed by reducing carbohydrate intake Dietary antioxidants play an important role in the development of adequate systemic reactions against oxidative stress Clinical and in vitro studies have shown that antioxidants in the diet have positive effects on periodontal tissues
Current studies report that there is a decrease in gum and periodontal diseases in the adult age group with a diet compatible with the Mediterranean diet It is known that the Mediterranean diet reduces the amount of periodontopathogenic species especially in supragingival plaque
This cross-sectional study aims to examine the relationship between a diet compatible with the Mediterranean Diet and dental caries and gum health status in children Secondly the nutritional habits and behaviors of the family and the effects of the childs daily energy and nutrient intake on oral and dental health will be examined
It is planned to include children between the ages of 0-14 who apply to Ankara Medipol University Oral and Dental Health Practice and Research Center Pedodontics Clinic Parents of children who meet the study criteria will be informed about the research and an informed consent form will be obtained Parents who volunteer to participate in the study will be asked to fill out the Demographic data form Mediterranean Diet Quality Index KIDMED and Family Nutrition and Physical Activity FNPA screening tool Additionally a retrospective 24-hour food consumption record will be taken Afterwards oral and dental examinations of the children will be performed and the data obtained will be recorded
Information on how to reach the participants Families and children who meet the inclusion criteria and volunteer to participate in the study will be included in the patients who apply to the pedodontics clinic
Forms used in data collection
Oral and dental examination indexes Oral examinations of children will be performed by a single experienced pediatric dentist using a mirror and probe in the dentists chair and under appropriate lighting Caries extracted due to caries filled primary and permanent teeth and tooth surfaces in the child will be evaluated according to the caries index criteria of the World Health Organization WHO-2013 Within the scope of evaluating plaque accumulation and gingival health the plaque index Silness Löe 1964 and gingival index Löe Silness 1963 will be calculated
Mediterranean Diet Quality Scale KIDMED
Turkish validity and reliability study of the Mediterranean Diet Quality Scale in children was conducted by Şahingöz et al 2019 The scale consists of 16 questions 12 of which have positive connotations and 4 of which have negative connotations While positive answers to questions with negative connotations are scored as -1 positive answers to questions with positive connotations are scored as 1 As a result of the scoring data ranging from 0-12 is obtained and evaluated in 3 main groups
1 Those with 8 points optimal Mediterranean diet good
2 Scores between 4 and 7 Those whose compliance with the Mediterranean diet needs improvement moderate
3 If 3 points very low nutritional quality low
Family Nutrition and Physical Activity screening tool FNPA The Family Nutrition and Physical Activity Screening Tool was developed by Ihmel et al from Iowa State University in collaboration with the Academy of Nutrition and Dietetics American Dietetic Association ADA in 2009 The original language of the FNPA scale is English The FNPA scale is a behaviorally based assessment that evaluates family environments and combines information from a variety of behaviors associated with childhood obesity and was designed as a screening tool with potential for use by obesity researchers and a variety of clinical and public health professionals The Turkish validity and reliability study was conducted by Ekici et al 2021 The Turkish form of this tool consists of 20 items and is evaluated in a four-point Likert type Each item is scored as 1 never rarely 2 sometimes 3 often and 4 very often always Six different items were reverse coded and these are items 3 4 5 7 10 and 13 The scores given to these items are summed up with the corresponding score in reverse order when calculating the total score 4 never rarely 3 sometimes 2 often and 1 very often always The total score obtained from the scale varies between 20-80 Since there is no cut-off value when comparing the total score high scores indicate less risky family practices and child behaviors for child obesity while low scores indicate high-risk family environments and practices and child behaviors
24-hour retrospective food consumption recordThe study will record individual daily food consumption with a 24-hour retrospective food consumption record using the Food Consumption Record FormThe researcher will ask the individuals included in the study about all the foods and drinks they consumed the day before including their quantities Daily energy and nutrient intakes of the individuals participating in the study will be calculated using the Nutrition Information Systems 82 program and the percentages of daily energy intake macro and micronutrients will be evaluated taking into account age and gender
Sample size The population of the study consists of healthy children between the ages of 0-14 The sample consists of healthy children who applied to Ankara Medipol University Oral and Dental Health Application and Research Center Pedodontics Clinic and those whose families volunteered to participate in the study The sample size was calculated with GPower 3192 For this purpose information obtained from previous similar studies Sáenz-Ravello et al 2023 was used as a reference Considering the effect size as 025 the margin of error as 005 and the power value as 080 it was determined that at least 159 subjects were required
Statistical Methods
The data obtained from the study will be evaluated with the SPSS 260 Statistical Package for Social Science statistical program First of all the distribution and skewness of the data will be evaluated with normality tests and will be expressed as mean χ and standard deviation SD or median M lower and upper values Parametric t-test or non-parametric Mann-Whitney U test hypothesis tests are suitable for numericalquantitative data when comparing the difference between two independent groups For qualitative data the appropriate chi-square test PearsonFisher will be used Appropriate correlation analysis SpearmanPearsonEta coefficient will be performed to determine the relationship between numerical and qualitative variables The value of p005 will determine statistical significance
The Mediterranean diet AD is a healthy nutritional model and the risk of major chronic inflammatory diseases decreases with a diet highly compatible with MD It is thought that the protective effect of the Mediterranean diet is related to unsaturated fatty acids the amount of dietary fiber bioactive components and antioxidants It is known that diet affects the inflammatory reaction of periodontal tissues It is stated that inflammatory reactions in the gums cannot develop especially with a diet that does not contain refined carbohydrates It is reported in the literature that reducing carbohydrate intake and taking additional Omega-3 fatty acids vitamin C vitamin D antioxidants and fiber is beneficial for the health of periodontal tissues
While excessive carbohydrate intake increases dysbiosis and chronic inflammatory diseases a decrease in gingivitis has been observed by reducing carbohydrate intake Dietary antioxidants play an important role in the development of adequate systemic reactions against oxidative stress Clinical and in vitro studies have shown that antioxidants in the diet have positive effects on periodontal tissues
Current studies report that there is a decrease in gum and periodontal diseases in the adult age group with a diet compatible with the Mediterranean diet It is known that the Mediterranean diet reduces the amount of periodontopathogenic species especially in supragingival plaque
This cross-sectional study aims to examine the relationship between a diet compatible with the Mediterranean Diet and dental caries and gum health status in children Secondly the nutritional habits and behaviors of the family and the effects of the childs daily energy and nutrient intake on oral and dental health will be examined
It is planned to include children between the ages of 0-14 who apply to Ankara Medipol University Oral and Dental Health Practice and Research Center Pedodontics Clinic Parents of children who meet the study criteria will be informed about the research and an informed consent form will be obtained Parents who volunteer to participate in the study will be asked to fill out the Demographic data form Mediterranean Diet Quality Index KIDMED and Family Nutrition and Physical Activity FNPA screening tool Additionally a retrospective 24-hour food consumption record will be taken Afterwards oral and dental examinations of the children will be performed and the data obtained will be recorded
Information on how to reach the participants Families and children who meet the inclusion criteria and volunteer to participate in the study will be included in the patients who apply to the pedodontics clinic
Forms used in data collection
Oral and dental examination indexes Oral examinations of children will be performed by a single experienced pediatric dentist using a mirror and probe in the dentists chair and under appropriate lighting Caries extracted due to caries filled primary and permanent teeth and tooth surfaces in the child will be evaluated according to the caries index criteria of the World Health Organization WHO-2013 Within the scope of evaluating plaque accumulation and gingival health the plaque index Silness Löe 1964 and gingival index Löe Silness 1963 will be calculated
Mediterranean Diet Quality Scale KIDMED
Turkish validity and reliability study of the Mediterranean Diet Quality Scale in children was conducted by Şahingöz et al 2019 The scale consists of 16 questions 12 of which have positive connotations and 4 of which have negative connotations While positive answers to questions with negative connotations are scored as -1 positive answers to questions with positive connotations are scored as 1 As a result of the scoring data ranging from 0-12 is obtained and evaluated in 3 main groups
1 Those with 8 points optimal Mediterranean diet good
2 Scores between 4 and 7 Those whose compliance with the Mediterranean diet needs improvement moderate
3 If 3 points very low nutritional quality low
Family Nutrition and Physical Activity screening tool FNPA The Family Nutrition and Physical Activity Screening Tool was developed by Ihmel et al from Iowa State University in collaboration with the Academy of Nutrition and Dietetics American Dietetic Association ADA in 2009 The original language of the FNPA scale is English The FNPA scale is a behaviorally based assessment that evaluates family environments and combines information from a variety of behaviors associated with childhood obesity and was designed as a screening tool with potential for use by obesity researchers and a variety of clinical and public health professionals The Turkish validity and reliability study was conducted by Ekici et al 2021 The Turkish form of this tool consists of 20 items and is evaluated in a four-point Likert type Each item is scored as 1 never rarely 2 sometimes 3 often and 4 very often always Six different items were reverse coded and these are items 3 4 5 7 10 and 13 The scores given to these items are summed up with the corresponding score in reverse order when calculating the total score 4 never rarely 3 sometimes 2 often and 1 very often always The total score obtained from the scale varies between 20-80 Since there is no cut-off value when comparing the total score high scores indicate less risky family practices and child behaviors for child obesity while low scores indicate high-risk family environments and practices and child behaviors
24-hour retrospective food consumption recordThe study will record individual daily food consumption with a 24-hour retrospective food consumption record using the Food Consumption Record FormThe researcher will ask the individuals included in the study about all the foods and drinks they consumed the day before including their quantities Daily energy and nutrient intakes of the individuals participating in the study will be calculated using the Nutrition Information Systems 82 program and the percentages of daily energy intake macro and micronutrients will be evaluated taking into account age and gender
Sample size The population of the study consists of healthy children between the ages of 0-14 The sample consists of healthy children who applied to Ankara Medipol University Oral and Dental Health Application and Research Center Pedodontics Clinic and those whose families volunteered to participate in the study The sample size was calculated with GPower 3192 For this purpose information obtained from previous similar studies Sáenz-Ravello et al 2023 was used as a reference Considering the effect size as 025 the margin of error as 005 and the power value as 080 it was determined that at least 159 subjects were required
Statistical Methods
The data obtained from the study will be evaluated with the SPSS 260 Statistical Package for Social Science statistical program First of all the distribution and skewness of the data will be evaluated with normality tests and will be expressed as mean χ and standard deviation SD or median M lower and upper values Parametric t-test or non-parametric Mann-Whitney U test hypothesis tests are suitable for numericalquantitative data when comparing the difference between two independent groups For qualitative data the appropriate chi-square test PearsonFisher will be used Appropriate correlation analysis SpearmanPearsonEta coefficient will be performed to determine the relationship between numerical and qualitative variables The value of p005 will determine statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None