Back to resultsImpact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
Primary Purpose
Prosthesis Durability
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CAD/CAM Complete denture
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Durability
Eligibility Criteria
Inclusion Criteria: 1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture Exclusion Criteria: diabetic and heavy smoker patients
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture
Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture
Arm Description
Outcomes
Primary Outcome Measures
digital occlusal analysis
occlusion was analyzed by occlusense device
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06080815
Brief Title
Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
Official Title
Impact of Mandibular 4-Implant Overdenture Base Construction Techniques on Assessment of Occlusion With Digital Occlusion Analysis System (Within Patient Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
March 7, 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
This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense
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
Crossover Assignment
Model Description
According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups.
Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method.
Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture
Arm Type
Active Comparator
Arm Title
Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CAD/CAM Complete denture
Intervention Description
four implant-supported CAD/CAM complete overdenture
Primary Outcome Measure Information:
Title
digital occlusal analysis
Description
occlusion was analyzed by occlusense device
Time Frame
6 months
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:
1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture
Exclusion Criteria:
diabetic and heavy smoker patients
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
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