NCT03026894

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 9, 2017

Last Update Submit

January 19, 2017

Conditions

Bone Resorption

Outcome Measures

Primary Outcomes (1)

  • Residual ridge resorption

    To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.

    7 years

Secondary Outcomes (1)

  • Occlusal force distribution

    1 year

Study Arms (2)

CD group

ACTIVE COMPARATOR

Panoramic Radiographs and T-Scan III occlusal system

Radiation: Panoramic RadiographDevice: T-Scan III occlusal system

IOD group

ACTIVE COMPARATOR

Panoramic Radiographs and T-Scan III occlusal system

Radiation: Panoramic RadiographDevice: T-Scan III occlusal system

Interventions

Panoramic RadiographRADIATION

Measurement of bone resorption

CD groupIOD group
T-Scan III occlusal systemDEVICE

Recording percentage of force in maximum intercuspation

CD groupIOD group

Eligibility Criteria

Age49 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients wearing mandibular IODs opposing conventional maxillary CDs.
  • Patients wearing conventional maxillary and mandibular CDs.
  • Clearly visible anatomic landmarks of the panoramic radiography image.

You may not qualify if:

  • Patients with a history of temporomandibular joint dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Resorption

Interventions

Radiography, Panoramic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Radiography, DentalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnosis, OralDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 20, 2017

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share