Bone ResorptionNCT03026894
Association of Force Distribution and Bone Resorption
A study testing Panoramic Radiograph and T-Scan III occlusal system in people with Bone Resorption, run by University of Malaya.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Panoramic Radiograph and T-Scan III occlusal system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients wearing mandibular IODs opposing conventional maxillary CDs.
- Patients wearing conventional maxillary and mandibular CDs.
- Clearly visible anatomic landmarks of the panoramic radiography image.
Who cannot join
- Patients with a history of temporomandibular joint dysfunction.
About this study
Official title: Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures
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.
Read the 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.
- Conditions
- Bone Resorption
- Being tested
- Panoramic Radiograph, T-Scan III occlusal system
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panoramic RadiographRadiation
Measurement of bone resorption
T-Scan III occlusal systemDevice
Recording percentage of force in maximum intercuspation
| Study group | Role | What they receive |
|---|---|---|
| CD group | Active comparator | Panoramic Radiographs and T-Scan III occlusal system Receives: Radiation: Panoramic Radiograph; Device: T-Scan III occlusal system |
| IOD group | Active comparator | Panoramic Radiographs and T-Scan III occlusal system Receives: Radiation: Panoramic Radiograph; Device: T-Scan III occlusal system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual ridge resorption
To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.
Measured: 7 years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026894
- Sponsor's protocol ID
- PG012-2014A
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures
- ClinicalTrials.gov ID
- NCT03026894
- Acronym / sponsor ID
- PG012-2014A
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD group | Active comparator | Radiation: Panoramic Radiograph, Device: T-Scan III occlusal systemPanoramic Radiographs and T-Scan III occlusal system |
| IOD group | Active comparator | Radiation: Panoramic Radiograph, Device: T-Scan III occlusal systemPanoramic Radiographs and T-Scan III occlusal system |
Who may qualify
- Ages
- 49 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients wearing mandibular IODs opposing conventional maxillary CDs.
- Patients wearing conventional maxillary and mandibular CDs.
- Clearly visible anatomic landmarks of the panoramic radiography image.
Key exclusion criteria (1 listed)
- Patients with a history of temporomandibular joint dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panoramic RadiographMeasurement of bone resorption | Radiation | CD group, IOD group |
| T-Scan III occlusal systemRecording percentage of force in maximum intercuspation | Device | CD group, IOD group |
Primary outcome
Residual ridge resorption
Time frame: 7 years
To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.
1 secondary outcome
Occlusal force distribution
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Panoramic Radiograph and T-Scan III occlusal system in people with Bone Resorption, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual ridge resorption (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.