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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359093
Other study ID # 14422023557605
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date September 2026

Study information

Verified date April 2024
Source Cairo University
Contact Rowayda Anwar Eltarawy, MSc
Phone +201066517727
Email rowayda.anwar@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Moreover, to explore the associated risk indicators of the lesions as well as the quantity of saliva, as one of the potential etiological factors, will be assessed.


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 quantity for subgroup diagnosed with non-carious cervical lesions will be done.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1532
Est. completion date September 2026
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 41 Years to 60 Years
Eligibility Inclusion Criteria: - patients who attend the Diagnostic central clinic at the Cairo University Dental Educational Hospital. - patients of both genders, aged 41-60 years old. - patients that are able to read and understand the questionnaire that will be used in this study. Exclusion Criteria: - having extensive dental caries - having a dental prosthesis - having dental braces - previously undergoing tooth whitening.

Study Design


Locations

Country Name City State
Egypt Faculty of Dentistry Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Secondary 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
Day 1
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