(PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Overdenture

October 31, 2016 updated by: Ahmed Ibrahim Eldesoky Mohamed Elbakry, Cairo University

Effect of Polyether Ether Ketone (PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Implant Retained Overdentures: Randomized Clinical Trial

The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient should be free from any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking.etc.
  2. Patients have completely edentulous upper and lower arches.
  3. Patients have healthy mucosa free from any ulceration, inflammation or infections.
  4. All patients are free from neuromuscular and temporomandibular joint disorders.
  5. Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.

Exclusion Criteria:

  1. Patients with limited manual dexterity.
  2. Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia…etc.)
  3. Pregnant females.
  4. Un co-operative patients.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Metal housing
metal housing of ball and socket attachment the intervention will be overdenture
Other: Overdenture
Active comparator will be metal housing and peek housing
Other Names:
  • Implant supported overdenture
ACTIVE_COMPARATOR: Peek housing
Peek housing of ball and socket attachment the intervention will be overdenture
Other: Overdenture
Active comparator will be metal housing and peek housing
Other Names:
  • Implant supported overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention of implant supported overdenture by using digital force meter device
Time Frame: 3 months
3 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

October 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 25, 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-2016-10-230

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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