Back to resultsAll on Four Versus All on Three Implant Treatment Concepts
Primary Purpose
Prosthesis Durability
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
implant supported fixed full arch prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Durability
Eligibility Criteria
Inclusion Criteria: 1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts. 2. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician. 3. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures. Exclusion Criteria: 1. Any neuromuscular disorders 2. Uncooperative patients -
Sites / Locations
- Christine Ibrahim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
• Group 1 (control group)
• Group 2 (test group);
Arm Description
patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Outcomes
Primary Outcome Measures
patient satisfaction
Patient satisfaction was evaluated using a questionnaire based on visual analog scale (VAS)
crestal bone loss
bone loss was measured around the implants in mm
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05912127
Brief Title
All on Four Versus All on Three Implant Treatment Concepts
Official Title
All On-4 Versus All o-3 Implant Treatment Concepts for Rehabilitation of Atrophied Mandibular Ridge. A Study of Patient Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
October 9, 2022 (Actual)
Study Completion Date
June 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.
Detailed Description
Patients will be classified into 2 groups according to the implant treatment concept they received:
Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be classified into 2 groups according to the implant treatment concept they received:
Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
• Group 1 (control group)
Arm Type
Active Comparator
Arm Description
patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
Arm Title
• Group 2 (test group);
Arm Type
Active Comparator
Arm Description
patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Intervention Type
Device
Intervention Name(s)
implant supported fixed full arch prosthesis
Intervention Description
the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.
Primary Outcome Measure Information:
Title
patient satisfaction
Description
Patient satisfaction was evaluated using a questionnaire based on visual analog scale (VAS)
Time Frame
one year
Title
crestal bone loss
Description
bone loss was measured around the implants in mm
Time Frame
Two year
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:
1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.
2. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.
3. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.
Exclusion Criteria:
1. Any neuromuscular disorders 2. Uncooperative patients
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Elsyad, professor
Organizational Affiliation
professor of prosthodontics, Faculty of dentistry , Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christine Ibrahim
City
Mansoura
ZIP/Postal Code
P.O.Box:35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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All on Four Versus All on Three Implant Treatment Concepts
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