NCT03670797

Brief Summary

There are severe deficiency of database concerning the oral health status in Egyptian patients with Diabetes type 2. Our aim in the present study is to study the prevalence of oral mucosal alterations in type 2 DM patients and the effect of hyperglycemia on these alterations in controlled and uncontrolled patients to increase their awareness and minimize all the possible risk factors,to achieve a proper management for all oral problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 25, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

September 12, 2018

Last Update Submit

January 25, 2020

Conditions

Keywords

oral health statusoral findingsoral manifestationspatients with diabetes

Outcome Measures

Primary Outcomes (1)

  • Oral mucosal alterations

    Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).

    10 min

Secondary Outcomes (2)

  • Periodontal condition

    10 min

  • Salivary glands function

    10 min

Study Arms (2)

controlled diabetic patients

uncontrolled diabetic patients

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of adult patients diagnosed with diabetes type 2 attending at the Endocrine clinic at El Kasr Al-Ainy Cairo University Hospital will be enrolled in the study in a consecutive order.

You may qualify if:

  • Adult patients
  • Patients \>25years old
  • Patients diagnosed with diabetes type 2.
  • Egyptian patients.

You may not qualify if:

  • females diagnosed with gestational diabetes.
  • Patients not physically able to participate in survey or clinical oral examination.
  • Patients with other systemic diseases which may cause oral manifestation as liver disorders.
  • Patients under immunosuppressive drugs.
  • Patients under corticosteriods.
  • Patients with organ transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaa Mahmoud Abd El Kader

Cairo, 2020, Egypt

Location

Related Publications (2)

  • Al-Maweri SA, Ismail NM, Ismail AR, Al-Ghashm A. Prevalence of oral mucosal lesions in patients with type 2 diabetes attending hospital universiti sains malaysia. Malays J Med Sci. 2013 Jul;20(4):39-46.

  • Bastos AS, Leite AR, Spin-Neto R, Nassar PO, Massucato EM, Orrico SR. Diabetes mellitus and oral mucosa alterations: prevalence and risk factors. Diabetes Res Clin Pract. 2011 Apr;92(1):100-5. doi: 10.1016/j.diabres.2011.01.011. Epub 2011 Mar 3.

MeSH Terms

Conditions

Mouth DiseasesDiabetes MellitusOral Manifestations

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mariam fakhr

    the Endocrine units at the Kasr Al-Ainy Cairo university hospital.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator, internal resident at oral medicine department

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

December 25, 2018

Primary Completion

July 30, 2019

Study Completion

August 20, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations