Association of Force Distribution and Bone Resorption

Not Applicable

Completed

• Conditions: Bone Resorption
• Interventions: Radiation: Panoramic Radiograph; Device: T-Scan III occlusal system

• Registration Number: NCT03026894
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD group	T-Scan III occlusal system	Panoramic Radiographs and T-Scan III occlusal system
CD group	Panoramic Radiograph	Panoramic Radiographs and T-Scan III occlusal system
IOD group	Panoramic Radiograph	Panoramic Radiographs and T-Scan III occlusal system
IOD group	T-Scan III occlusal system	Panoramic Radiographs and T-Scan III occlusal system

Primary Outcome Measures

Name	Time	Method
Residual ridge resorption	7 years	To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.

Secondary Outcome Measures

Name	Time	Method
Occlusal force distribution	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.