- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05170529
Prevalence of Non-Carious Cervical Lesions in Patient With Gingival Recession and Associated Risk Factors
August 28, 2022 updated by: Omar Essam Ali, Cairo University
Prevalence of Non-Carious Cervical Lesions in Patient With Gingival Recession and Associated Risk Factors: A Hospital Based Cross-Sectional Study in a Sample of Adult Egyptian Dental Patients.
The study aims at determining the prevalence of non carious cervical lesions in patients with gingival recession in Egyptian population and associated risk factors including gingival biotype, keratinized tissue width, gingival index, plaque index, occlusal wear grade, sensitivity.
and a questionnaire will be filled by patients with another risk factors including age, gender, toothbrush frequency and type, bruxism, gastric reflux, soft drinks, alcohol and citrus fruits.
Also OHIP-14 will be answered in a questionnaire form by patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Dental patients will be recruited in a consecutive manner from diagnostic centre at Cairo University Dentistry faculty.
Patients with NCCL will be selected for questionnaires and clinical examination.
Thorough 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 done with face to face interview with the patient will include associated risk factors including gingival biotype, keratinized tissue width, gingival index, plaque index, occlusal wear grade, sensitivity.
and a questionnaire will be filled by patients with another risk factors including age, gender, toothbrush frequency and type, bruxism, gastric reflux, soft drinks, alcohol and citrus fruits.
Also OHIP-14 will be answered in a questionnaire form by patients including: functional limitations, physical pain, psychological discomfort, physical disability, psychological disability, social disability, handicap.
then clinical examination will be done for NCCL using mirror, probe, light of the unit, air tip.
Study Type
Observational
Enrollment (Actual)
362
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 12613
- Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
adult Egyptian patients with gingival recession attending the dental diagnostic centre in Cairo university
Description
Inclusion Criteria:
- adult patients with NCCL and gingival recession whose age is above 15 years old
- patients consulting in dental Diagnostic Centre, faculty of dentistry, Cairo University
- patients provide informed consent
Exclusion Criteria:
- patients having problem in mouth opening or undergoing intermaxillary fixation where oral examination is not possible
- patients diagnosed with psychiatric problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession
Time Frame: Day 1
|
clinical examination
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health related-quality of life (OHR-QoL) OHIP-14 questionnaire
Time Frame: Day 1
|
questionnaire
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 10, 2022
Primary Completion (ACTUAL)
June 18, 2022
Study Completion (ACTUAL)
June 20, 2022
Study Registration Dates
First Submitted
December 7, 2021
First Submitted That Met QC Criteria
December 27, 2021
First Posted (ACTUAL)
December 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 28, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.