Evaluation of Patient Satisfaction and Biting Force of New Design of Extracoronal Attachment (O T Cap Unilateral Attachment) Versus Conventional Partial Denture for Treatment of Unilateral Mandibular Distal Extension Area

October 31, 2016 updated by: Mohamed mamdouh afify, Cairo University
Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with unilateral mandibular distal extension area
  • Normal crown/root ratio of last premolar
  • co-operative patients

Exclusion Criteria:

  • completely edentulous patient
  • few remaining teeth
  • patients exposed to radiotherapy and chemotherapy
  • patients with maxillary or mandibular defect

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional partial denture
Intervention will be O T unilateral attachment
Other: O T unilateral attachment
O T unilateral attachment system
Active Comparator: Conventional removal partial denture
Intervention will be new design of extra coronal attachment( O T unilateral attachment)
Other: New design of extracoronal attachment system
O T unilateral attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 12 months
OHIP-14 questionnaire
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Biting force
Time Frame: 12 months
12 months

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

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 29, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CEBD-CU-2016-10-232

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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