Back to resultsBone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One
Primary Purpose
Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electric intraoral weilding
casting
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption
Eligibility Criteria
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.
Sites / Locations
- Cairo University ,Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
electric welded metal framework
conventional cast metal technique
Arm Description
using electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors
using the conventional casting technique to join metal framework and compare it with the electric welding technique
Outcomes
Primary Outcome Measures
bony changes assessment
assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04548258
Brief Title
Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electric welded metal framework
Arm Type
Experimental
Arm Description
using electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors
Arm Title
conventional cast metal technique
Arm Type
Experimental
Arm Description
using the conventional casting technique to join metal framework and compare it with the electric welding technique
Intervention Type
Device
Intervention Name(s)
electric intraoral weilding
Intervention Description
weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally
Intervention Type
Device
Intervention Name(s)
casting
Intervention Description
casting metal framework
Primary Outcome Measure Information:
Title
bony changes assessment
Description
assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
faculty of dentistry cairo university
Phone
0235676105
Ext
+2
Email
dentmail@dentistry.cu.edu.eg
Facility Information:
Facility Name
Cairo University ,Faculty of Dentistry
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of dentistry cairo dentistry
First Name & Middle Initial & Last Name & Degree
cairo university faculty of dentistry
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One
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