Association of Force Distribution and Bone Resorption
Primary Purpose
Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Panoramic Radiograph
T-Scan III occlusal system
Sponsored by
About this trial
This is an interventional basic science trial for Bone Resorption
Eligibility Criteria
Inclusion Criteria:
- Patients wearing mandibular IODs opposing conventional maxillary CDs.
- Patients wearing conventional maxillary and mandibular CDs.
- Clearly visible anatomic landmarks of the panoramic radiography image.
Exclusion Criteria:
- Patients with a history of temporomandibular joint dysfunction.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CD group
IOD group
Arm Description
Panoramic Radiographs and T-Scan III occlusal system
Panoramic Radiographs and T-Scan III occlusal system
Outcomes
Primary Outcome Measures
Residual ridge resorption
To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.
Secondary Outcome Measures
Occlusal force distribution
To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03026894
Brief Title
Association of Force Distribution and Bone Resorption
Official Title
Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the residual ridge resorption at anterior and posterior maxillary and posterior mandibular ridges among conventional complete dentures and implant overdenture wearers, and determine its association with the relative occlusal forces distribution, treatment groups and other patient variables.
Detailed Description
A total of forty-six edentulous patients participated in this clinical study divided into two groups as following; complete denture group (CD) consists of 23 patients wearing conventional complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical bone area and the reference area in the maxillary and the mandibular ridges. The occlusal contacts percentage of force in maximum intercuspation anteriorly and posteriorly were recorded for both groups by using T-Scan III system.
Oral and written information in English or Malay language, regarding the study, was provided and written consent obtained before enrolment.
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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD group
Arm Type
Active Comparator
Arm Description
Panoramic Radiographs and T-Scan III occlusal system
Arm Title
IOD group
Arm Type
Active Comparator
Arm Description
Panoramic Radiographs and T-Scan III occlusal system
Intervention Type
Radiation
Intervention Name(s)
Panoramic Radiograph
Intervention Description
Measurement of bone resorption
Intervention Type
Device
Intervention Name(s)
T-Scan III occlusal system
Intervention Description
Recording percentage of force in maximum intercuspation
Primary Outcome Measure Information:
Title
Residual ridge resorption
Description
To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Occlusal force distribution
Description
To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients wearing mandibular IODs opposing conventional maxillary CDs.
Patients wearing conventional maxillary and mandibular CDs.
Clearly visible anatomic landmarks of the panoramic radiography image.
Exclusion Criteria:
Patients with a history of temporomandibular joint dysfunction.
12. IPD Sharing Statement
Plan to Share IPD
No
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Association of Force Distribution and Bone Resorption
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