NCT06701565

Brief Summary

This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in this population. The study examines the relationship between glycemic control (e.g., HbA1c levels) and the severity of caries, as well as the impact of diabetes-related changes in oral health, such as gum recession and dry mouth, on the development of both coronal and radicular caries. The findings could inform preventive strategies and dental care guidelines tailored for diabetic patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 20, 2024

Last Update Submit

December 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • prevalence of coronal caries

    DMFT Index developed by World Health Organization (WHO) using number scores and percentage

    One year

  • prevalence of radicular caries

    Radicular caries by International Caries and Assessment System (ICDAS II)

    One year

Secondary Outcomes (4)

  • Blood Glucose level

    One year

  • Salivary flow

    One year

  • Salivary pH

    One year

  • Caries risk related factors

    one year

Study Arms (2)

Controlled type 2 diabetes

Uncontrolled type 2 diabetes

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

1. Patient whose age between 30-65 2. Diabetic patients 3. Patient consulting in the outpatient clinic 4. Co-operative patient 5. Males \& Females 6. Egyptian

You may qualify if:

  • Patient whose age between 30-65
  • Diabetic patients
  • Patient consulting in the outpatient clinic
  • Co-operative patient
  • Males \& Females
  • Egyptian

You may not qualify if:

  • Patients under or over this age group
  • Lack of compliance
  • Disabilities
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental CariesRoot CariesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

December 15, 2024

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

December 4, 2024

Record last verified: 2024-11