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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02996123
Other study ID # EKF 54324
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 12, 2016
Last updated December 14, 2016
Start date October 2016
Est. completion date December 2017

Study information

Verified date December 2016
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: National Research Center
Study type Interventional

Clinical Trial Summary

measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.


Description:

measuring difference in biting force using i-load device with followup period of 6 months


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 63
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

1. Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge.

2. Mean age of 50-75 years of age.

3. The edentulous ridges should be covered by firm healthy mucosa.

4. Systemically free; no history of diabetes, chemotherapy, and radiotherapy.

5. Co-operative patients.

Exclusion Criteria:

1. Patients with severely resorbed maxillary ridge

2. Previous history of radiotherapy or chemotherapy.

3. Patients with xerostomia

4. Patients with neuromuscular and hormonal disorders

5. Patients with severe bony or soft tissue undercuts

6. Patients with large tongue

7. Patients with limited mouth opening

8. Patients with known history of allergy, especially to acrylic resin

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
cad/cam maxillary dentures
patients wearing cad/cam designed and milled dentures

Locations

Country Name City State
Egypt Cairo university Cairo Governorate

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases 6 month No