Association of Force Distribution and Bone Resorption

Bone Resorption Clinical Trial

Official title:

Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026894
• Other study ID #: PG012-2014A
• Status: Completed
• Phase: N/A
• First received: January 9, 2017
• Last updated: January 19, 2017
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 49 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Radiation:
• Panoramic Radiograph
Measurement of bone resorption

Device:
• T-Scan III occlusal system
Recording percentage of force in maximum intercuspation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual ridge resorption	To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.	7 years
Secondary	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.	1 year