NCT03167632

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
605

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

May 24, 2017

Last Update Submit

May 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of Oral Ulcers

    number of patients having oral ulcers

    3 months

Secondary Outcomes (4)

  • Oral health related-quality of life (OHR-QoL).

    3 months

  • The effect of previous treatment

    3 months

  • Types of non-conventional treatments used

    3 months

  • Number of dentists or physicians visited before

    3 months

Study Arms (1)

dental patients

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Subjects whose age was above 15 years old.

You may not qualify if:

  • Subjects having problem in opening their mouth (due to non-oral ulcer cause) or undergoing intermaxillary fixation where oral examination was not possible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Oral Ulcer

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

August 10, 2015

Primary Completion

October 25, 2015

Study Completion

October 25, 2015

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

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.