Back to resultsSoft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted
Primary Purpose
Peri-Implantitis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Electric intraoral welding device
casting
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
Eligibility Criteria
Inclusion Criteria:
- Ages 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 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 flappy ridge.
- 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 casted metal framework
Arm Description
Outcomes
Primary Outcome Measures
Soft Tissue Changes Assessment
Primary outcome is the probing depth which will be measured using the periodontal probe (unit mm) around the implant to check the changes that may occur in the peri-implant soft tissues
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04543864
Brief Title
Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted
Official Title
Soft Tissue Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Casted One (RCT, Split Mouth Design)
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 the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method
Detailed Description
as joining multiple implants by a metal framework considered a solid solution for edentulous arches , but in the same time the conventional method to weld this metal framework to the implants by casting technique in lab usually involves a several disadvantages eg. cost and time consuming in addition to laboratory errors, Thus , this study aims to find another method to weld the metal framework intraorally by an electric welding device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
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 Title
conventional casted metal framework
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electric intraoral welding device
Intervention Description
welding metal framework to the implants in completely edentulous maxilla by electric welding device intraorally
Intervention Type
Device
Intervention Name(s)
casting
Intervention Description
casting the metal framework
Primary Outcome Measure Information:
Title
Soft Tissue Changes Assessment
Description
Primary outcome is the probing depth which will be measured using the periodontal probe (unit mm) around the implant to check the changes that may occur in the peri-implant soft tissues
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:
Ages 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 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 flappy ridge.
Parafunctional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
faculty of dentistry,cairo university Cairo university
Phone
+20235676105
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 university
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted
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