Management of Loading Forces Distribution in Mandibular Distal-extension Prostheses

Study Overview
=================
Brief Summary
-----------------
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: Implant support on distal extension removable. 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. Altered-cast technique. 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
-----------------
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.

Official Title
-----------------
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)

Conditions
-----------------
Mandibular Distal-extension Prostheses

Intervention / Treatment
-----------------
* Procedure: Altered cast technique
* Device: Precision Attachments
* Procedure: Resilient layer


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft-tissue vertical displacement (STVD) | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Loading Forces, Removable partial dentures, Bilateral distal extension