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OpenTrials
Completed

NCT Number: NCT03026894

Association of Force Distribution and Bone Resorption

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.

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Key information

Conditions

Bone Resorption Bone Diseases Musculoskeletal Diseases

Age range

49 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Panoramic Radiograph

Radiation

Measurement of bone resorption

T-Scan III occlusal system

Device

Recording percentage of force in maximum intercuspation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2017
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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