NCT04548258

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

August 28, 2020

Last Update Submit

October 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • bony changes assessment

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

    12 months

Study Arms (2)

electric welded metal framework

EXPERIMENTAL

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

conventional cast metal technique

EXPERIMENTAL

using the conventional casting technique to join metal framework and compare it with the electric welding technique

Device: casting

Interventions

weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally

electric welded metal framework
castingDEVICE

casting metal framework

conventional cast metal technique

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with recent extraction(less than three months).
  • Patients with inflamed ridge or candida infection.
  • Patients with flappyridge.
  • Parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University ,Faculty of Dentistry

Cairo, 11553, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

faculty of dentistry cairo university

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 14, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations