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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04548258
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: electric intraoral weilding
  • Device: casting
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Bone Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Cast One (Randomized Control,Split Mouth Trial)
Anticipated Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. bony changes assessment [12 months]

    assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University ,Faculty of Dentistry Cairo Egypt 11553

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shaimaa Magdy Abd Elhakm Mohmed, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04548258
Other Study ID Numbers:
  • 6420
First Posted:
Sep 14, 2020
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bone Resorption

Study Results

No Results Posted as of Oct 6, 2020