Association of Force Distribution and Bone Resorption

January 19, 2017 updated by: University of Malaya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CD group
Panoramic Radiographs and T-Scan III occlusal system
Radiation: Panoramic Radiograph
Measurement of bone resorption
Device: T-Scan III occlusal system
Recording percentage of force in maximum intercuspation
Active Comparator: IOD group
Panoramic Radiographs and T-Scan III occlusal system
Radiation: Panoramic Radiograph
Measurement of bone resorption
Device: T-Scan III occlusal system
Recording percentage of force in maximum intercuspation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal force distribution
Time Frame: 1 year
To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG012-2014A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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