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

Dental Prosthesis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06082609
• Other study ID #: A0104023RP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: December 16, 2024

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 16, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Prosthesis Complication

Intervention

Procedure:
• Removable partial denture
All patients will receive Removable partial denture by two different impression techniques

Locations

Country	Name	City	State
Egypt	Mansoura University ,Faculty of dentistry	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abutment alveolar bone loss	Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year	Two year