Clinical Assessment of CAD/CAM Monolithic Complete Denture

NCT ID: NCT07091552

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2025-04-05

Brief Summary

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The aim of the study is to evaluate trueness, tooth position, retention, and patient satisfaction of CAD/CAM monolithic complete denture

Detailed Description

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Conditions

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Complete Denture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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CAD/CAM monolithic denture

Group Type EXPERIMENTAL

CAD/CAM monolithic denture

Intervention Type DEVICE

Based on the workflow suggested by the Ivoclar digital denture, conventional complete dentures will be scanned by using desktop scanner (Medit T710). The cameo and intaglio surfaces of the complete dentures will be scanned, and the scanned data will be exported as Standard Tessellation Language (STL) file to start the milling process.

For the milling process, monolithic denture will be milled from a bicolored disk (Ivotion). One side is the denture base material made of high impact optimized polymethyl methacrylate (PMMA) while the other is the teeth material made of highly cross-linked PMMA with no filler. The bicolor disk is milled in a 5-axis milling machine in wet condition, through an uninterrupted milling process. Following the fast milling process the dentures will be finished and polished.

Conventional denture

Group Type ACTIVE_COMPARATOR

Conventional denture

Intervention Type DEVICE

The conventional set will be fabricated with the 5-appointment process: preliminary impressions (first appointment); definitive impressions (second appointment); interocclusal records and tooth selection (third appointment), the size of the teeth will be selected according to the library provided by 3Shape Dental System software to match the disc size; wax trial placement (fourth appointment); and denture adjustment and placement (fifth appointment). Conventional CD will be fabricated with the conventional lost wax technique and heat-polymerizing acrylic resin. The heat-polymerized CDs will be finished, and polished before placement. Adjustments will be made for the polished surface, tissue surface, borders, and occlusion. Occlusal errors will be adjusted through clinical remount of the finished dentures.

Interventions

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CAD/CAM monolithic denture

Based on the workflow suggested by the Ivoclar digital denture, conventional complete dentures will be scanned by using desktop scanner (Medit T710). The cameo and intaglio surfaces of the complete dentures will be scanned, and the scanned data will be exported as Standard Tessellation Language (STL) file to start the milling process.

For the milling process, monolithic denture will be milled from a bicolored disk (Ivotion). One side is the denture base material made of high impact optimized polymethyl methacrylate (PMMA) while the other is the teeth material made of highly cross-linked PMMA with no filler. The bicolor disk is milled in a 5-axis milling machine in wet condition, through an uninterrupted milling process. Following the fast milling process the dentures will be finished and polished.

Intervention Type DEVICE

Conventional denture

The conventional set will be fabricated with the 5-appointment process: preliminary impressions (first appointment); definitive impressions (second appointment); interocclusal records and tooth selection (third appointment), the size of the teeth will be selected according to the library provided by 3Shape Dental System software to match the disc size; wax trial placement (fourth appointment); and denture adjustment and placement (fifth appointment). Conventional CD will be fabricated with the conventional lost wax technique and heat-polymerizing acrylic resin. The heat-polymerized CDs will be finished, and polished before placement. Adjustments will be made for the polished surface, tissue surface, borders, and occlusion. Occlusal errors will be adjusted through clinical remount of the finished dentures.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Completely edentulous patients, and willing to participate and sign the informed consent.
* No cognitive or psychological deficits.
* Moderate arch size with moderate undercut.
* No retrognathic or prognathic jaw relationship. (Normal horizontal ridge relationship)

Exclusion Criteria

* Participants having undercuts, flabby ridge, severely resorbed ridges.
* Participants with noticeably poor neuromuscular control, hyposalivation, general health, or other issues rendering repeated appointments difficult.
* Oral mucosa exhibits papillary hyperplasia or pathologic changes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Eman Assam

OTHER

Sponsor Role lead

Responsible Party

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Eman Assam

Assistant Lecturer of Prosthodontics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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9208697

Identifier Type: -

Identifier Source: org_study_id

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