NCT04539210

Brief Summary

In this study the investigators are going to compare the effect of electric welded metal frame work and cast frame work on patient satisfaction and maintenance of the final prosthesis.

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 Sep 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

September 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

August 25, 2020

Last Update Submit

September 3, 2020

Conditions

Patient SatisfactionMaintenance

Keywords

electric weldingmetal framework

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    satisfaction assessed by Boerrigter's method questionnaire.in this questionnaire, there are three aspects to consider:(1) problems with the denture itself;(2) masticating ability; and (3) overall denture performance. different answers to each question are assigned scores and the total score can be calculated for further evaluation and analysis.

    12 months

Secondary Outcomes (1)

  • Maintenance of the final prosthesis

    12 months

Study Arms (2)

Electric Welded Metal Framework

EXPERIMENTAL

A preexisting or prepared flat surface area of the welding abutment of implant at central incisor position at one side (right or left) will serve as the welding point. A titanium bar will be shaped following the curvature of the implants positioned. At this point, temporary titanium implant abutments will be welded with the titanium bar in the oral cavity, using the Syncrystallization Unit. Finally, the prosthetic framework, created by welding the titanium bar to the implant abutments, will be removed and opaque will be applied in order to avoid metal shining through the acrylic resin. The framework is picked up to denture with hard liner, and screwed to the denture.

Device: Electric Welded Metal Framework

cast metal framework

EXPERIMENTAL

On a verified analogue model, occlusion blocks will be constructed for adjustment of vertical dimension and bite registration. Afterwards, CCM abutments will be fastened over the analogues of the placed implants, followed by waxing, spruing and casting. The resultant cast metal framework will be inserted inside the patient's mouth on the right or left installed implants to insure passivity of fit. In case of framework misfit, separation will be performed using a disc, followed by intraoral splinting and soldering. After framework soldering, another try-in will be done to insure framework fit.

Device: Electric Welded Metal Framework

Interventions

Electric Welded Metal FrameworkDEVICE

Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework

Electric Welded Metal Frameworkcast metal framework

Eligibility Criteria

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

You may qualify if:

  • Age range from 45 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 bone 10mm and a minimum diameter of bone 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 flappy ridge.
  • Para functional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11553, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • cairo university

    cu

    STUDY DIRECTOR

Central Study Contacts

faculty of dentistry,cairo university

CONTACT

02 35676105dentmail@dentistry.cu.edu.eg

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
Principal Investigator

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 4, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

September 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)