Management of Loading Forces Distribution in Mandibular Distal-extension Prostheses

NCT ID: NCT02178384

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mandibular Distal-extension Prostheses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Altered-cast technique

Removable partial dentures will be made using altered-cast technique for free saddles.

Group Type EXPERIMENTAL

Altered cast technique

Intervention Type PROCEDURE

This techniques deals with the procedures that are employed when constructing the removable partial denture on working casts.

Precision attachments

Removable partial dentures will be made using precision attachments which will be located on the distal abutment teeth.

Group Type ACTIVE_COMPARATOR

Precision Attachments

Intervention Type DEVICE

These are minor attachments used to split the loading forces during appliance wear

Resilient layer

Removable partial dentures will be made using a resilient-layer on the distal extension of each appliance.

Group Type ACTIVE_COMPARATOR

Resilient layer

Intervention Type PROCEDURE

This is a layer beneath the appliance which helps in reducing the transmission of loading forces to the underlying soft tissues

Interventions

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Altered cast technique

This techniques deals with the procedures that are employed when constructing the removable partial denture on working casts.

Intervention Type PROCEDURE

Precision Attachments

These are minor attachments used to split the loading forces during appliance wear

Intervention Type DEVICE

Resilient layer

This is a layer beneath the appliance which helps in reducing the transmission of loading forces to the underlying soft tissues

Intervention Type PROCEDURE

Other Intervention Names

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Modified case technique Joint Attachments Flexible layer

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fadi Alhaji Jnaid, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus

Alaa' Salloum, DDS MSc PhD

Role: STUDY_DIRECTOR

Senior Lecturer, Removable Prosthodontics Department, University of Damascus Dental School, Damascus

Locations

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Department of Removable Prosthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

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Syria

References

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Pellizzer EP, Ferraco R, Tonella BP, Oliveira BJ, Souza FL, Falcon-Antenucci RM. Influence of ridge type on mandibular distal extension removable partial denture. Acta Odontol Latinoam. 2010;23(1):68-73.

Reference Type BACKGROUND
PMID: 20645647 (View on PubMed)

Aydinlik E, Akay HU. Effect of a resilient layer in a removable partial denture base on stress distribution to the mandible. J Prosthet Dent. 1980 Jul;44(1):17-20. doi: 10.1016/0022-3913(80)90039-6.

Reference Type BACKGROUND
PMID: 6991675 (View on PubMed)

Kratochvil FJ, Thompson WD, Caputo AA. Photoelastic analysis of stress patterns on teeth and bone with attachment retainers for removable partial dentures. J Prosthet Dent. 1981 Jul;46(1):21-8. doi: 10.1016/0022-3913(81)90129-3.

Reference Type BACKGROUND
PMID: 7024514 (View on PubMed)

Holmes JB. Influence of impression procedures and occlusal loading on partial denture movement. 1965. J Prosthet Dent. 2001 Oct;86(4):335-41. doi: 10.1067/mpr.2001.119826. No abstract available.

Reference Type BACKGROUND
PMID: 11677525 (View on PubMed)

Igarashi Y, Ogata A, Kuroiwa A, Wang CH. Stress distribution and abutment tooth mobility of distal-extension removable partial dentures with different retainers: an in vivo study. J Oral Rehabil. 1999 Feb;26(2):111-6. doi: 10.1046/j.1365-2842.1999.00345.x.

Reference Type BACKGROUND
PMID: 10080307 (View on PubMed)

Leupold RJ, Flinton RJ, Pfeifer DL. Comparison of vertical movement occurring during loading of distal-extension removable partial denture bases made by three impression techniques. J Prosthet Dent. 1992 Aug;68(2):290-3. doi: 10.1016/0022-3913(92)90332-5.

Reference Type BACKGROUND
PMID: 1501177 (View on PubMed)

Vahidi F. Vertical displacement of distal-extension ridges by different impression techniques. J Prosthet Dent. 1978 Oct;40(4):374-7. doi: 10.1016/0022-3913(78)90115-4.

Reference Type BACKGROUND
PMID: 359787 (View on PubMed)

Saito M, Miura Y, Notani K, Kawasaki T. Stress distribution of abutments and base displacement with precision attachment- and telescopic crown-retained removable partial dentures. J Oral Rehabil. 2003 May;30(5):482-7. doi: 10.1046/j.1365-2842.2003.01092.x.

Reference Type BACKGROUND
PMID: 12752927 (View on PubMed)

Tebrock OC, Rohen RM, Fenster RK, Pelleu GB Jr. The effect of various clasping systems on the mobility of abutment teeth for distal-extension removable partial dentures. J Prosthet Dent. 1979 May;41(5):511-6. doi: 10.1016/0022-3913(79)90082-9.

Reference Type BACKGROUND
PMID: 374712 (View on PubMed)

Other Identifiers

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UDDS-RemPro-01-2014

Identifier Type: -

Identifier Source: org_study_id

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