Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One

October 4, 2020 updated by: Shaimaa Magdy Abd Elhakm Mohmed, Cairo University

Bone Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Cast One (Randomized Control,Split Mouth Trial)

comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

joining multiple implants together in the edentulous arches is considered agood solution, using the conventional casting technique has many disadvantages due to lab errors and time and cost consuming on ,the other hand the study aims to owercome these disadvantages using electric welding metal framework.

Study Type

Interventional

Enrollment (Anticipated)

12

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11553
        • Recruiting
        • Cairo University ,Faculty of Dentistry
        • Contact:
          • faculty of dentistry cairo dentistry
        • Contact:
          • cairo university faculty of dentistry

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

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range from 30 to 65 years old.
  • Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
  • The patients must be completely edentulous.
  • The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
  • Patients with good oral hygiene.
  • Complete denture wearer.
  • Adequate inter arch space for screw retained prosthesis.
  • Absence of any intra-oral pathological condition.

Exclusion Criteria:

Patients with recent extraction(less than three months).

  • Patients with inflamed ridge or candida infection.
  • Patients with flappyridge.
  • Parafunctional habits.

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
EXPERIMENTAL: electric welded metal framework
using electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors
Device: electric intraoral weilding
weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally
EXPERIMENTAL: conventional cast metal technique
using the conventional casting technique to join metal framework and compare it with the electric welding technique
Device: casting
casting metal framework

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bony changes assessment
Time Frame: 12 months
assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.
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 (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (ACTUAL)

September 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 4, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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