Two Versus Four Implant-supported Fixed Full-arch Prosthesis
Primary Purpose
Prosthesis Durability
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
placement of four dental implants
placement of two dental implants
mandibular full arch prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Durability
Eligibility Criteria
Inclusion Criteria:
- • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I
Exclusion Criteria:
- systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
Sites / Locations
- Faculty of Dentistry, Mansoura University
- Christine Ibrahim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
Study group
Arm Description
will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
Outcomes
Primary Outcome Measures
Visual analog scale (VAS) questionnaire
Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance
crestal bone loss
measuring marginal bone loss in mm around dental implants by digital radiography
plaque index
evaluation of plaque accumulation around dental implants using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter
gingival index
evaluation of gingival bleeding using scoring system as following: scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.
pocket depth
evaluation of pocket depth in mm around dental implants
Secondary Outcome Measures
Quality of Life (Secondary Outcome).
The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains
prosthesis maintenance and survival rate
measuring the survival rate of the mandibular prosthesis in both groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290766
Brief Title
Two Versus Four Implant-supported Fixed Full-arch Prosthesis
Official Title
Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2020 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
April 16, 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 aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.
Detailed Description
Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.
The patients will be divided into 2 groups
Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
Intervention Type
Procedure
Intervention Name(s)
placement of four dental implants
Intervention Description
placement of four dental implants according to the " All on four concept"
Intervention Type
Procedure
Intervention Name(s)
placement of two dental implants
Intervention Description
placement of two dental implants according to " All on two concepts"
Intervention Type
Device
Intervention Name(s)
mandibular full arch prosthesis
Intervention Description
loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) questionnaire
Description
Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance
Time Frame
one year
Title
crestal bone loss
Description
measuring marginal bone loss in mm around dental implants by digital radiography
Time Frame
one year
Title
plaque index
Description
evaluation of plaque accumulation around dental implants using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter
Time Frame
one year
Title
gingival index
Description
evaluation of gingival bleeding using scoring system as following: scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.
Time Frame
one year
Title
pocket depth
Description
evaluation of pocket depth in mm around dental implants
Time Frame
one year
Secondary Outcome Measure Information:
Title
Quality of Life (Secondary Outcome).
Description
The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains
Time Frame
one year
Title
prosthesis maintenance and survival rate
Description
measuring the survival rate of the mandibular prosthesis in both groups
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I
Exclusion Criteria:
systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
Facility Information:
Facility Name
Faculty of Dentistry, Mansoura University
City
Mansoura
State/Province
Eldakahlia
ZIP/Postal Code
35516
Country
Egypt
Facility Name
Christine Ibrahim
City
Mansoura
ZIP/Postal Code
P.O.Box:35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Two Versus Four Implant-supported Fixed Full-arch Prosthesis
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