Oral Ulcer Prevalence: Hospital-based Cross-sectional Study

Oral Ulcer Clinical Trial

Official title:

Oral Ulcer Prevalence of and Quality of Life: a Hospital-based Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167632
• Other study ID #: QoL1
• Status: Completed
• Phase: N/A
• First received: May 24, 2017
• Last updated: May 25, 2017
• Start date: August 10, 2015
• Est. completion date: October 25, 2015

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Oral Ulcers have serious effect on patients' lives. Due to absence of any information about its prevalence, risk factors and effect on patients' lives, this study has been held. The investigators recruited patients from the outpatient dental clinic of the faculty of oral and dental medicine, Cairo University, screened them clinically for oral ulcers. All patients filled questionnaires about the risk factors of oral ulcers. Furthermore, oral ulcer patients filled questionnaires about their Quality of life, previous treatments used, previous physicians visited and their Quality of life after using previous treatments.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: October 25, 2015
• Est. primary completion date: October 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Ulcer
• Ulcer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of Oral Ulcers	number of patients having oral ulcers	3 months
Secondary	Oral health related-quality of life (OHR-QoL).	Quality of life of patients having oral ulcers	3 months
Secondary	The effect of previous treatment	measured by: OHIP-14 at the end of treatment and the time interval of ulcer-free period after stoppage of treatment.	3 months
Secondary	Types of non-conventional treatments used	reported together with its side effects as nominal outcomes.	3 months
Secondary	Number of dentists or physicians visited before	Also the specialties of these physicians reported	3 months