Oral UlcerNCT03167632
Oral Ulcer Prevalence: Hospital-based Cross-sectional Study
An observational study of Oral Ulcer, run by Cairo University.
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Oral Ulcer
- How many people
- 605 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2015to 25 Oct 2015
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients attending the outpatient clinic of oral diagnosis, department of Oral Medicine, Oral Diagnosis and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Who may be able to join
- Subjects whose age was above 15 years old.
Who cannot join
- Subjects having problem in opening their mouth (due to non-oral ulcer cause) or undergoing intermaxillary fixation where oral examination was not possible.
About this study
Official title: Oral Ulcer Prevalence of and Quality of Life: a Hospital-based Cross-sectional Study
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.
Read the 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.
- Conditions
- Oral Ulcer
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dental patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of Oral Ulcers
number of patients having oral ulcers
Measured: 3 months
Secondary outcomes (4)
Oral health related-quality of life (OHR-QoL).
Quality of life of patients having oral ulcers
Measured: 3 months
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.
Measured: 3 months
Types of non-conventional treatments used
reported together with its side effects as nominal outcomes.
Measured: 3 months
Number of dentists or physicians visited before
Also the specialties of these physicians reported
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start10 Aug 2015
- Primary completion25 Oct 2015
- Study completion25 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral UlcerStudies 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
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Gamal-AbdelNaser, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167632
- Sponsor's protocol ID
- QoL1
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Whenever asked for meta-analysis, the IPD will be available in the form of an excel sheet having no identifiers, where each patient is given an ID number of the study.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ulcer Prevalence of and Quality of Life: a Hospital-based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03167632
- Acronym / sponsor ID
- QoL1
- Conditions
- Oral Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 25 Oct 2015 (actual)
- Study completion
- 25 Oct 2015 (actual)
- First posted
- 30 May 2017 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dental patients | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients attending the outpatient clinic of oral diagnosis, department of Oral Medicine, Oral Diagnosis and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Key inclusion criteria (1 listed)
- Subjects whose age was above 15 years old.
Key exclusion criteria (1 listed)
- Subjects having problem in opening their mouth (due to non-oral ulcer cause) or undergoing intermaxillary fixation where oral examination was not possible.
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 Oral Ulcers
Time frame: 3 months
number of patients having oral ulcers
4 secondary outcomes
Oral health related-quality of life (OHR-QoL).
Time frame: 3 months
The effect of previous treatment
Time frame: 3 months
Types of non-conventional treatments used
Time frame: 3 months
Number of dentists or physicians visited before
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: Yes. Whenever asked for meta-analysis, the IPD will be available in the form of an excel sheet having no identifiers, where each patient is given an ID number of the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Ulcer, run by Cairo University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Oral Ulcers (time frame: 3 months). 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 30 May 2017.