Functional Relining Versus Digital Altered Cast Using Digitally Fabricated Distal Extension Frameworks

Functional Relining Versus Digital Altered Cast Of Selective Pressure Impression Techniques Using Digitally Fabricated Distal Extension Frameworks: Abutment Alveolar Bone Height Changes

This clinical study will be done to compare between functional relining and digital altered cast of selective pressure impression techniques for constructing mandibular distal extension removable partial dentures using digitally fabricated frameworks by measuring the abutment alveolar bone height changes.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Prosthesis Complication
• Intervention / Treatment: Procedure: Removable partial denture

Detailed Description

According to the functional impression techniques, all patients will be classified into two equal groups:

Group A: Functional relining of processed RPD base at insertion:

•After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.The finished removable partial denture is relined using the functional relining impression technique.

Group B : Digitally obtained altered cast :

Selective pressure impression technique will be made.

Digital altered cast will be done according to J. Wu, Y. Cheng (20) as follow :

All patients will be informed about the follow up and evaluation recalls.

Evaluation of abutment alveolar bone height changes:

Alveolar bone height changes of abutment teeth will be evaluated radiographically at insertion (T0), and after 6 (T6) & 12 months (T12) after RPD insertion.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University ,Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. All patients having completely edentulous maxilla opposing class I Kennedy mandible.

  2. Sufficient restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.

  3. Well formed residual ridge covered by healthy firm mucosa. 4. All patients are of angel's class I maxillo-mandibular relationships. 5. Abutment teeth must fulfil certain criteria:

  1. Abutment teeth should be healthy with good periodontal and bone support.
  2. Should not show a pronounced degree of mobility or advanced gingival recession.

  3. Crown Root Ratio of abutment teeth not more than 1:2

     Exclusion Criteria:

• 1. Sever soft tissue undercuts. 2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.

  3. History of radiotherapy in the head and neck region.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: • Group 1 (Functional relining of processed RPD base at insertion); After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.; Registration of jaw relation.; Mounting of master casts on articulator.; Setting of artificial teeth according to lingualized occlusion principles.; Try in of RPD.; Flasking of RPD to obtain mandibular distal extension removable partial dentures.; The finished removable partial denture is relined using the functional relining impression technique.	Procedure: Removable partial denture; All patients will receive Removable partial denture by two different impression techniques
Active Comparator: • Group 2 (Digitally obtained altered cast ); Construction of custom tray on metal frame work.; Border molding of custom tray.; Selective pressure impression technique will be made.; Digital altered cast will be done according to J. Wu, Y. Cheng; 3D printing of altered master cast that will be used for completing the construction of RPD with the same steps of group (A) but without relining.Finally the occlusion of dentures in the two groups will be verified before delivery.	Procedure: Removable partial denture; All patients will receive Removable partial denture by two different impression techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abutment alveolar bone loss	Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year	Two year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): April 20, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A0104023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No