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

NCT05899712 | Completed

• 1 other identifier: A0203023RP
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study compares between digital and conventional altered cast techniques using digitally constructed frameworks in removable partial dentures' construction regarding their effect on bone height changes around abutment teeth and in residual ridge.

Conditions

Denture, Partial, Removable

Outcome Measures

Primary Outcomes (1)

• Alveolar Bone Height Changes

  Alveolar bone height changes of abutment teeth and residual ridge.

  one year

Study Arms (2)

Group A

ACTIVE COMPARATOR

Digitally obtained altered cast for construction of mandibular free end saddle removable partial denture

Other: Removable Partial Denture Construction

Group B

ACTIVE COMPARATOR

Conventionally obtained altered cast for construction of mandibular free end saddle removable partial denture

Other: Removable Partial Denture Construction

Interventions

Removable Partial Denture Construction OTHER

Construction of class I Removable partial denture by digital workflow

Group A; Group B

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients having completely edentulous maxilla and class I Kennedy mandible.
• 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.
• All patients are of angel's class I maxillo-mandibular relationships
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlyia, 35111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: June 12, 2023
• Study Start: May 15, 2023
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: June 18, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)