Non-carious Cervical LesionsNCT06359093
Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients.
An observational study of Non-carious Cervical Lesions, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Read more about this study
- Who is it for?
- Ages 41 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- How many people
- 1,532 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2024to Sep 2026
- 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 41 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital.
Who may be able to join
- Patients whose age between 41-60 years old.
- Patient consulting in the outpatient clinic
- Provide informed consent.
- Males \& Females
- Egyptian
Who cannot join
- Patients under or over this age group.
- Refuse to participate in the study.
- Wearing orthodontic appliance.
- The presence of trismus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients Attending the Cairo University Dental Educational Hospital: Analytical Cross-Sectional Study
The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the flow rate and pH of saliva, as one of the potential etiological factors, will be assessed.
Read the detailed description
Dental patients will be recruited from diagnostic central clinic at the Cairo University Dental Educational Hospital. Oral examination will be done, the full aim of the study will be explained to the patient, and patient acceptance is a must. The questionnaire will be filled by patients including age, gender, occupation, education, place of residence, toothbrushing: included frequency, method, intensity, hardness and duration, biting and chewing habits, medical history [related to gastrointestinal problems such as belching, heartburn, vomiting, gastro-oesophageal reflux (GER), peptic ulcer disease], eating disorders (anorexia, bulimia), medication list, frequency of consuming acidic food and fruits, carbonated beverages and alcohol and smoking status. Salivary assessment regarding flow rate and pH for a subgroup diagnosed with non-carious cervical lesions.
- Conditions
- Non-carious Cervical Lesions
- Keywords
- patient-related risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital.
clinical examination
Measured: Day 1
Secondary outcomes (1)
Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions.
questionnaire will be used to collect data. For quantitative analysis of saliva: if saliva flow rate is less than 1ml/min , it is considered xerostomia.
If saliva flow rate is less than 1ml/min , it is low salivary flow if saliva flow rate is more than 3, it is high salivary flow
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-carious Cervical LesionsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 1,532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowayda Anwar Hosny Eltarawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359093
- Sponsor's protocol ID
- 14422023557605
- Status last verified
- Aug 2024
- First submitted
- 6 Apr 2024
- Last updated
- 22 Aug 2024
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients Attending the Cairo University Dental Educational Hospital: Analytical Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06359093
- Acronym / sponsor ID
- 14422023557605
- Conditions
- Non-carious Cervical Lesions
- Keywords
- patient-related risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,532 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Apr 2024 (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 aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the flow rate and pH of saliva, as one of the potential etiological factors, will be assessed.
Detailed description
Dental patients will be recruited from diagnostic central clinic at the Cairo University Dental Educational Hospital. Oral examination will be done, the full aim of the study will be explained to the patient, and patient acceptance is a must. The questionnaire will be filled by patients including age, gender, occupation, education, place of residence, toothbrushing: included frequency, method, intensity, hardness and duration, biting and chewing habits, medical history [related to gastrointestinal problems such as belching, heartburn, vomiting, gastro-oesophageal reflux (GER), peptic ulcer disease], eating disorders (anorexia, bulimia), medication list, frequency of consuming acidic food and fruits, carbonated beverages and alcohol and smoking status. Salivary assessment regarding flow rate and pH for a subgroup diagnosed with non-carious cervical lesions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 41 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital.
Key inclusion criteria (5 listed)
- Patients whose age between 41-60 years old.
- Patient consulting in the outpatient clinic
- Provide informed consent.
- Males \& Females
- Egyptian
Key exclusion criteria (4 listed)
- Patients under or over this age group.
- Refuse to participate in the study.
- Wearing orthodontic appliance.
- The presence of trismus.
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
Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital.
Time frame: Day 1
clinical examination
1 secondary outcome
Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
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 Non-carious Cervical Lesions, run by Cairo University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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 Egypt. 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?
Contact Rowayda Anwar Eltarawy, MSc (+201066517727, rowayda.anwar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital. (time frame: Day 1). 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 Aug 2024.