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

December 14, 2016 updated by: Ahmed Erfan Gamal El Dein, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo Governorate, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cad/cam maxillary dentures
single maxillary dentures fabricated by cad/cam method
Other: cad/cam maxillary dentures
patients wearing cad/cam designed and milled dentures
Active Comparator: conventional dentures
heat cured single maxillary dentures
Other: cad/cam maxillary dentures
patients wearing cad/cam designed and milled dentures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKF 54324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

charts with measurements and readings collected will be recorded and available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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