Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures. (OTCap)

October 3, 2016 updated by: Rania Hassan, Cairo University

Treatment Outcomes Based on Patient's Oral Health Related Quality of Life (OHRQoL) After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures in Distal Extension Cases: A Randomized Controlled Clinical Trial

PICOTS:

P: Kennedy class І patients

I : Mandibular removable partial denture with OT Cap attachment

C: Mandibular removable partial denture with gingival approaching clasp assembly

O: 1ry outcome: Oral Health Related Quality of Life

2ry outcome: Biting force

T: 1 Year

S : Randomized control trial

Research question:

In Kennedy class І patients will the removable partial denture with OT Cap attachment compared to conventional removable partial denture with clasp assembly results in difference in Oral Health Related Quality of Life of Patients?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In bilateral edentulous mandible with missing molars, the clasp retained partial denture will be compared with precision attachment partial denture for better quality of life for patients.

Study Type

Interventional

Enrollment (Anticipated)

32

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, Egypt, 11553
        • faculty of oral and dental medicine, 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 mandibular free end saddle cases.
  2. Patients less than 75 years old.
  3. Patients who approved to be included in the trial and signed the informed consent.
  4. Patients are not suffering from diabetes mellitus.

Exclusion Criteria:

  1. Patients are suffering from diabetes mellitus.
  2. Patients above 75 years old.
  3. Patients are receiving chemotherapy or radiotherapy.
  4. Patients with severe Temporomandibular Joint problems.
  5. Patients who refused the trial.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Mandibular removable partial denture with OT Cap attachment
Device: OT Cap attachment
The RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics.
No Intervention: Comparator
Mandibular removable partial denture with gingival approaching clasp assembly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health Related Quality of Life
Time Frame: 1 Year
Questionnaire
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biting force
Time Frame: 1 Year
i-load Star Sensor
1 Year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Yousr M. Mady, Professor, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
  • Study Director: Ahmed M. Fayyad, A. Professor, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt

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

November 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2016-09-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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