Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases

Bites, Human Clinical Trial

Official title:

Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases: A Randomized Controlled Trial .

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02996123
• Other study ID #: EKF 54324
• 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

• Bites, Human

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