Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: Alveolar Bone Height Changes

This clinical study compares between digital and conventional removable partial dentures' construction techniques using digitally approaches regarding their effect on bone height changes of abutment teeth and residual ridge.

Study Overview

• Status: Recruiting
• Conditions: Denture, Partial, Removable
• Intervention / Treatment: Other: Removable Partial Denture Construction

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah Safaa Abozied, MSc; Phone Number: 00201065001901; Email: aabozied@horus.edu.eg

Study Locations

• Egypt
  • Dakahlyia
    • Mansoura, Dakahlyia, Egypt, 35111
      • Recruiting
      • Mansoura University
      • Contact: Abdullah Safaa Abozied, MSc; Phone Number: 00201065001901; Email: aabozied@horus.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. All patients having completely edentulous maxilla and class I Kennedy mandible.
2. Sufficient (not less than 15 mm) 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. All patients are of angel's class I maxillo-mandibular relationships
4. Abutment teeth must meet certain requirements :

A. Abutment teeth should be healthy with good periodontal and bone support. B. should not show advanced destructions. C. should not show a pronounced degree of mobility or advanced gingival recession.

D. Crown Root Ratio for an abutment is 1:2

Exclusion Criteria:

1. Sever undercuts or concavities on the buccal or lingual sides of the ridge.
2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
3. History of radiotherapy in the head and neck region.
4. Crown Root Ratio for an abutment is 1:1.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Digitally obtained altered cast for construction of mandibular free end saddle removable partial denture	Other: Removable Partial Denture Construction; Construction of class I Removable partial denture by digital workflow
Active Comparator: Group B; Conventionally obtained altered cast for construction of mandibular free end saddle removable partial denture	Other: Removable Partial Denture Construction; Construction of class I Removable partial denture by digital workflow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar Bone Height Changes	Alveolar bone height changes of abutment teeth and residual ridge.	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: June 3, 2023
• First Submitted That Met QC Criteria: June 3, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A0203023RP

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