Management of Loading Forces Distribution in Mandibular Distal-extension Prostheses

October 2, 2015 updated by: Damascus University

An In-vivo Study to Evaluate Three Methods of Managing the Distribution of Loading Forces in Mandibular Distal-extension Prostheses (Class I Kennedy's Classification)

The two structures that support a mandibular distal extension removable partial denture differ markedly in their visco-elastic response to loading. The difference between the resilience of the residual ridge tissues and the teeth permitted by the periodontal ligament presents a disparity of support that is in contrast to the uniform support accorded a tooth-supported removable partial denture. Hence the denture tends to rotate about its most distal abutments, inducing heavy torsional stresses on alveolar ridges.

Many methods have been used to control this movement, some of them:

  1. Implant support on distal extension removable.
  2. Stress breakers provide a mean of interposing a flexible connection between the tooth-borne retainer portion of removable partial denture and its distally extended tissue-borne segment.
  3. Altered-cast technique.
  4. Design development by using mesial indirect retainers rather than distal ones.

The purpose of this study is: (1) to compare bone absorption around abutment teeth nearby the free saddle; (2) denture displacement and pressure on the soft tissue under the denture base of distal extension RPD (Removable Partial Denture) (3) cellular changes in the soft tissue under the denture base of distal extension RPD.

Study Overview

Detailed Description

Removable partial dentures (RPD) have an essential role in treating partly edentulous. patients with large toothless spaces, or without posterior dental support (Kennedy Class I).

Rehabilitation with Distal-Extension Removable Partial Denture (DERPD) deserves special attention because of the difference in resilience between the remaining mucosa of the edentulous area and the periodontal ligament of the abutment tooth. When occlusal forces affect the bases, the difference in resilience between the mucosa of the edentulous area and the periodontal ligament of the abutment teeth creates a rotating movement whose axis is located on the occlusal rests on the abutment teeth. This may induce horizontal forces and mainly lateral forces upon them, causing inflammation, gingival retraction, increase in dental mobility and distal residual ridge resorption. This movement may cause a reduction in function, discomfort and trauma to the RPD supporting tissues.

MATERIAL AND METHODS:

Patients will be recruited from the Department of Prosthodontics at the University of Damascus Dental School. Thirty patients will be randomly divided into three groups (A, B, and C). A mandibular bilateral distal-extension removable partial denture will be used for patients in all groups. But every group will have its own specific method of distributing loading forces.

In Group A: A Removable partial dentures will be made by using altered-cast technique for free saddle.The investigators will make a primary impression using stock tray. This will be followed by a final impression by individual tray. After metal framework try-in, ridge regions are removed from uncorrected master cast with saw. Then, corrective impression of ridges will be obtained with soft ZOE impression paste. Therefore, a metal framework with associated corrective impression will be repositioned on tooth portion of master cast prior to altering distal-extension bases.

In Group B: Removable partial dentures will be made by using precision attachments which will be located on the last abutment tooth. At first, crowns will be prepared to receive the precision attachment, then these are cemented to their respective abutment teeth. So that a mean of interposing a flexible connection between the tooth-borne retainer portion of a removable partial denture and its distally extended tissue-borne base will be provided.

In Group C: Removable partial dentures will be made by using resilient-layer in the distal extension of the removable partial denture.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of removable prosthodontics, University of Damascus Dental School

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

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral distal extension in the mandible (Class I Kennedy's Classification).
  • Stable systemic health, including absence of a history of cardiovascular disease.
  • No evidence of infection or trauma in the oral region.
  • Negative history of syndromes or temporomandibular disorders and parafunction.

Exclusion Criteria:

  • Other Classes of Kennedy's Classification
  • Patients with ages beyond the accepted age range.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Altered-cast technique
Removable partial dentures will be made using altered-cast technique for free saddles.
This techniques deals with the procedures that are employed when constructing the removable partial denture on working casts.
Other Names:
  • Modified case technique
Active Comparator: Precision attachments
Removable partial dentures will be made using precision attachments which will be located on the distal abutment teeth.
These are minor attachments used to split the loading forces during appliance wear
Other Names:
  • Joint Attachments
Active Comparator: Resilient layer
Removable partial dentures will be made using a resilient-layer on the distal extension of each appliance.
This is a layer beneath the appliance which helps in reducing the transmission of loading forces to the underlying soft tissues
Other Names:
  • Flexible layer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft-tissue vertical displacement (STVD)
Time Frame: This variable will be measured at one month, three months and six months following appliance first delivery
Soft tissue vertical displacement will be measured using an impression technique at the free end saddles.
This variable will be measured at one month, three months and six months following appliance first delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone absorption of abutment teeth
Time Frame: This variable will be measured at one month, three months and six months following appliance first delivery
The amount bone absorption will be measured using apical radiography.
This variable will be measured at one month, three months and six months following appliance first delivery
Cellular changes of the supporting tissues
Time Frame: This variable will be measured at one month, three months and six months following appliance first delivery
A brush will be used to have a smear of the underlying soft tissues. Cellular changes will be evaluated microscopically. The changes observed will be analysed quantitatively.
This variable will be measured at one month, three months and six months following appliance first delivery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Fadi Alhaji Jnaid, DDS MSc, PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus
  • Study Director: Alaa' Salloum, DDS MSc PhD, Senior Lecturer, Removable Prosthodontics Department, University of Damascus Dental School, Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • UDDS-RemPro-01-2014

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.

Clinical Trials on Mandibular Distal-extension Prostheses

Clinical Trials on Altered cast technique

Subscribe