AdolescentNCT06803511
Dietary Acid Load and Oral Health Quality in Adolescents
An observational study of Adolescent, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent
- Type of treatment
- Pill or oral medicine
- How many people
- 374 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Jun 2024
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Community sample in Türkiye
Who may be able to join
- 14-18 ages
Who cannot join
- those with diagnosed eating disorders
- those with diagnosed psychiatric
- those with diagnosed cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06760
About this study
Official title: Investigating the Relationship Between Dietary Acid Load and Oral Health-Related Quality of Life in Adolescents
This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Dietary acid load was assessed using PRAL and NEAP calculations. Data analysis was performed with SPSS 24 to explore the impact of diet composition on adolescents' oral health.
Read the detailed description
Introduction: Oral health plays a crucial role in the psychological and physical development of children and adolescents. The composition of the diet consumed significantly affects oral health.
Objective: This study aimed to examine the relationship between dietary acid load and oral health-related quality of life in adolescents.
Method: A total of 374 high school students (226 females, 148 males) participated in the study. Adolescents completed a demographic questionnaire and the Oral Health Impact Profile-14 (OHIP-14) scale, and 24-hour retrospective food consumption records were collected. Dietary acid load was assessed by calculating potential renal acid load (PRAL) and net endogenous acid production (NEAP) based on macronutrient and micronutrient intake from food records. Data analysis was conducted using the SPSS 24 software package.
- Conditions
- Adolescent
- Keywords
- Dietary acid load, oral health, quality of life, adolescents
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 |
|---|---|---|
| Adolescents | This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Dietary acid load was assessed using PRAL and NEAP calculations. Data analysis was performed with SPSS 24 to explore the impact of diet composition on adolescents' oral health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Impact Profile-14 Score
This scale was used to assess the quality of life related to oral health and how oral health affects overall quality of life and general health.
The scale consists of 14 items with 5-point Likert-type questions (each option ranging from 0 to 4 points) and was designed using a five-choice scaling method. It was concluded that as the total score increased, the severity of the problem also increased, leading to a decrease in quality of life.
Measured: Baseline
Calculation of Dietary Acid Load
Dietary acid load (DAL), potential renal acid load (PRAL), and net endogenous acid production (NEAP) were calculated based on the 24 hours food consumption record The formula for PRAL is as follows:
PRAL (mEq/day) = 0.4888 x protein (g/day) +0.0366 x phosphorus (mg/day)-0.0205 x potassium (mg/day) - 0.0125 x calcium (mg/day) - 0.0263 x magnesium (mg/day) NEAP (mEq/day) = [54.5 x protein (g/day) / potassium (mEq/day)] - 10.2 High and positive PRAL and NEAP values indicate a high dietary acid load.
Measured: Baseline
Secondary outcomes (4)
Sociodemographic characteristics
Sociodemographic characteristics will be assessed using a structured questionnaire developed by the researchers. The questionnaire will include items measuring age, gender, education level, and income status. The results will be presented as numbers and percentages for each characteristic.
Measured: Baseline
Body Mass Index (BMI)
Kilograms per square meter (kg/m2)
Measured: Baseline
Height
Height in cm
Measured: Baseline
Body weight
Body weight in kg
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2023
- Primary completion15 May 2023
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Elibol, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803511
- Sponsor's protocol ID
- AYBUELİBOL007
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Dietary Acid Load and Oral Health-Related Quality of Life in Adolescents
- ClinicalTrials.gov ID
- NCT06803511
- Acronym / sponsor ID
- AYBUELİBOL007
- Conditions
- Adolescent
- Keywords
- Dietary acid load, oral health, quality of life, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 31 Jan 2025 (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.
This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Dietary acid load was assessed using PRAL and NEAP calculations. Data analysis was performed with SPSS 24 to explore the impact of diet composition on adolescents' oral health.
Detailed description
Introduction: Oral health plays a crucial role in the psychological and physical development of children and adolescents. The composition of the diet consumed significantly affects oral health.
Objective: This study aimed to examine the relationship between dietary acid load and oral health-related quality of life in adolescents.
Method: A total of 374 high school students (226 females, 148 males) participated in the study. Adolescents completed a demographic questionnaire and the Oral Health Impact Profile-14 (OHIP-14) scale, and 24-hour retrospective food consumption records were collected. Dietary acid load was assessed by calculating potential renal acid load (PRAL) and net endogenous acid production (NEAP) based on macronutrient and micronutrient intake from food records. Data analysis was conducted using the SPSS 24 software package.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Dietary acid load was assessed using PRAL and NEAP calculations. Data analysis was performed with SPSS 24 to explore the impact of diet composition on adolescents' oral health. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Community sample in Türkiye
Key inclusion criteria (1 listed)
- 14-18 ages
Key exclusion criteria (3 listed)
- those with diagnosed eating disorders
- those with diagnosed psychiatric
- those with diagnosed cancer
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
Oral Health Impact Profile-14 Score
Time frame: Baseline
This scale was used to assess the quality of life related to oral health and how oral health affects overall quality of life and general health. The scale consists of 14 items with 5-point Likert-type questions (each option ranging from 0 to 4 points) and was designed using a five-choice scaling method. It was concluded that as the total score increased, the severity of the problem also increased, leading to a decrease in quality of life.
Calculation of Dietary Acid Load
Time frame: Baseline
Dietary acid load (DAL), potential renal acid load (PRAL), and net endogenous acid production (NEAP) were calculated based on the 24 hours food consumption record The formula for PRAL is as follows: PRAL (mEq/day) = 0.4888 x protein (g/day) +0.0366 x phosphorus (mg/day)-0.0205 x potassium (mg/day) - 0.0125 x calcium (mg/day) - 0.0263 x magnesium (mg/day) NEAP (mEq/day) = [54.5 x protein (g/day) / potassium (mEq/day)] - 10.2 High and positive PRAL and NEAP values indicate a high dietary acid load.
4 secondary outcomes
Sociodemographic characteristics
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Height
Time frame: Baseline
Body weight
Time frame: Baseline
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 31 Jan 2025.
- Individual participant dataSharing planned: No
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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 Adolescent, run by Ankara Yildirim Beyazıt 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 1 inclusion and 3 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 31 Jan 2025. 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?
Oral Health Impact Profile-14 Score (time frame: Baseline). 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 31 Jan 2025.