- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03167632
Oral Ulcer Prevalence: Hospital-based Cross-sectional Study
Oral Ulcer Prevalence of and Quality of Life: a Hospital-based Cross-sectional Study
Study Overview
Status
Conditions
Detailed Description
Oral ulcers form a category of oral lesions that is frequently encountered by the dentist. It influences the patients' lives greatly. In a first step to reducing the disease burdens on patients, basic data about the disease distribution and possible risk factors should be gathered through epidemiological studies.
This cross-sectional study consisted of a convenience sample of 605 dental patients recruited in the time from August to October 2015. The study was held in the outpatient oral diagnosis clinic, Faculty of Oral and Dental Medicine, Cairo University, Egypt; which is an open public facility, a tertiary healthcare and a referral center.
For each participant, the study details were explained and the consent was received. Then, medical history was taken, comprehensive oral examination was done, history of any detected oral ulcer was investigated. The questionnaire was filled through a face-to-face interview.
Comprehensive oral examination was held on a dental unit using the light of the unit, mirror and probe.
After full examination and questionnaire filling, the oral ulcer patients were educated about their oral problem and their ulcers were managed. If the patient's condition needed further investigations or management, referral was done to the appropriate department of the faculty.
The Questionnaire included a section for demographic information of age, sex, social and educational levels of the patient. It also included questions about medical condition, habits of trauma, smoking and its frequency.
After examination, if an ulcer was detected, a part of the questionnaire was filled describing the ulcer: site, size, number, shape, distribution, depth, edges, floor, margins, induration and regional lymph node status. Also, the (OHIP-14) questionnaire was filled to assess the effect of the ulcer on the patient's quality of life.
The questionnaire included questions about previous treatments used by the patients, the patients' assessment of their effect and the source of the patients' information about these therapies.
The patients was also asked about their previous experiences with dentists or physicians seeked to treat these ulcers.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects whose age was above 15 years old.
Exclusion Criteria:
- Subjects having problem in opening their mouth (due to non-oral ulcer cause) or undergoing intermaxillary fixation where oral examination was not possible.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
dental patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of Oral Ulcers
Time Frame: 3 months
|
number of patients having oral ulcers
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral health related-quality of life (OHR-QoL).
Time Frame: 3 months
|
Quality of life of patients having oral ulcers
|
3 months
|
The effect of previous treatment
Time Frame: 3 months
|
measured by: OHIP-14 at the end of treatment and the time interval of ulcer-free period after stoppage of treatment.
|
3 months
|
Types of non-conventional treatments used
Time Frame: 3 months
|
reported together with its side effects as nominal outcomes.
|
3 months
|
Number of dentists or physicians visited before
Time Frame: 3 months
|
Also the specialties of these physicians reported
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QoL1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Oral Ulcer
-
Chulalongkorn UniversityCompletedOral Ulcer | Orthodontic Appliances, FixedThailand
-
Yuzuncu Yıl UniversityCompleted
-
Ryan J. HalterNational Institutes of Health (NIH); National Institute of Dental and Craniofacial... and other collaboratorsRecruiting
-
October 6 UniversityCompletedLidocaine | Healing | Mebo | Traumatic Oral UlcerationEgypt
-
Hadassah Medical OrganizationCompletedOral Lesion | Oral Mucositis | Oral Mucosal Ulceration
-
Hadassah Medical OrganizationGrant from "Axiomedic. Advanced Medical Solutions", Zurich, SwitzerlandSuspended
-
University of Santiago de CompostelaAlfonso X El Sabio UniversityCompleted
-
HaEmek Medical Center, IsraelCompleted
-
Beni-Suef UniversityCompletedOral Ulcer Due to Pemphius Vularis | Oral Ulcer Due to Benign Mucous Membrane Pemphioid | Oral Ulcer Due to Steven Johnson's SyndromeEgypt
-
Dow University of Health SciencesNot yet recruiting