NCT07705672

Brief Summary

This study evaluated the effect of fixed prosthodontic rehabilitation on metabolic parameters and masticatory efficiency in patients with ischemic heart disease. Clinical and laboratory outcomes was assessed before and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 6, 2026

Last Update Submit

July 10, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Hemoglobin A1c (HbA1c)

    Hemoglobin A1c (HbA1c) (%) measured using standard laboratory methods. The mean change in HbA1c from baseline to 6 months after fixed prosthodontic rehabilitation will be assessed.

    Baseline and 6 months after fixed prosthodontic rehabilitation

  • Change in High-Density Lipoprotein Cholesterol (HDL-C)

    High-density lipoprotein cholesterol (HDL-C) concentration (mg/dL) measured using standard laboratory blood analysis. The mean change in HDL-C from baseline to 6 months after fixed prosthodontic rehabilitation will be assessed.

    Baseline and 6 months after fixed prosthodontic rehabilitation

  • Change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Low-density lipoprotein cholesterol (LDL-C) concentration (mg/dL) measured using standard laboratory blood analysis. The mean change in LDL-C from baseline to 6 months after fixed prosthodontic rehabilitation will be assessed.

    Baseline and 6 months after fixed prosthodontic rehabilitation

Study Arms (1)

Fixed Prosthodontic Rehabilitation

EXPERIMENTAL

Placement of fixed prosthodontic restorations to replace missing teeth and improve masticatory function in patients with ischemic heart disease.

Procedure: Fixed Prosthodontic Rehabilitation

Interventions

Placement of fixed prosthodontic restorations to replace missing teeth and improve masticatory function.

Fixed Prosthodontic Rehabilitation

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 45 to 70 years with diagnosed stable ischemic heart disease.
  • Patients presenting with partial edentulism and compromised masticatory function due to missing teeth.
  • Patients indicated for fixed prosthodontic rehabilitation.
  • Patients with complete clinical records and laboratory data available at baseline and 6 months after treatment.
  • Patients who provided informed consent for treatment and use of their clinical data.

You may not qualify if:

  • uncontrolled systemic diseases affecting metabolic status (e.g., uncontrolled diabetes mellitus).
  • acute cardiovascular events or unstable ischemic heart disease.
  • Patients with conditions affecting oral function other than tooth loss (e.g., neuromuscular disorders).
  • Patients who received removable prostheses instead of fixed prosthodontic rehabilitation.
  • Patients with incomplete clinical records or missing baseline or 6-month laboratory data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of fixed prosthodontics

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 15, 2026

Study Start

January 1, 2024

Primary Completion

September 12, 2025

Study Completion

November 30, 2025

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations