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

NCT06082609 | Unknown

• 1 other identifier: A0104023RP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Prosthesis Complication

Outcome Measures

Primary Outcomes (1)

• abutment alveolar bone loss

  Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year

  Two year

Study Arms (2)

• Group 1 (Functional relining of processed RPD base at insertion)

ACTIVE COMPARATOR

* 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

• Group 2 (Digitally obtained altered cast );

ACTIVE COMPARATOR

1. Construction of custom tray on metal frame work. 2. Border molding of custom tray. 3. Selective pressure impression technique will be made. 4. Digital altered cast will be done according to J. Wu, Y. Cheng 5. 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

Interventions

Removable partial denture PROCEDURE

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

• Group 1 (Functional relining of processed RPD base at insertion); • Group 2 (Digitally obtained altered cast );

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients having completely edentulous maxilla opposing class I Kennedy mandible.
• \. 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.
• \. 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:
• Abutment teeth should be healthy with good periodontal and bone support.
• Should not show a pronounced degree of mobility or advanced gingival recession.
• Crown Root Ratio of abutment teeth not more than 1:2

You may not qualify if:

• \. Sever soft tissue undercuts. 2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
• \. History of radiotherapy in the head and neck region.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University ,Faculty of dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Interventions

Denture, Partial, Removable

Intervention Hierarchy (Ancestors)

Denture, Partial; Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: h. 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 Group B : Digitally obtained altered cast

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 13, 2023
• Study Start: April 10, 2023
• Primary Completion: April 20, 2024
• Study Completion: December 16, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)