Clinical Assessment of CAD/CAM Monolithic Complete Denture

Not Applicable

Completed

• Conditions: Complete Denture

• Registration Number: NCT07091552
• Lead Sponsor: Eman Assam

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-12
• Primary Completion: 2025-04-05
• Study Completion: 2025-04-05
• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Accuracy of tooth position	Baseline (Day 1)	Accuracy will be verified by superimposing the tooth region data from the heat-cured and monolithic dentures on the tooth region data from the wax dentures using best fit algorithm of 3D data analytical software and measuring the displacement of the tooth arrangement. In addition, colour maps will be created using the 3D comparison function to visually display the direction and amount of tooth displacement. Using the software, a total of 48 measurement points will be established for maxillary dentures. Twenty-four measurement points will be defined on the anterior teeth: at the cusp tip or center of the incisal edge; at the mesio- and disto-incisal angles; and at the center of the lingual face of each tooth. Similarly, 24 measurement points will be defined on the posterior teeth at the cusp tips of each tooth. The average value of the dentures will be calculated for each of the 48 measurement points, and this will be used as the representative value of the measurement point.
Objective assessment of complete denture retention	Baseline (Day 1)	Retention will be evaluated objectively by using digital force gauge that will be connected to a wire loop which is attached on the denture bases. This force will be measured in newtons (N) and recorded as the denture's retention. A total of 3 measurements will be made for each denture by the same investigator. The highest value will be recorded as the peak retention force and used for the analysis
Patient satisfaction	up to 6 months	A patient satisfaction questionnaire will be designed according to the Guckes questionnaires. Subjects will be asked eight questions that pertained to their satisfaction with their conventional or monolithic dentures. The responses: completely satisfied, partially satisfied, and dissatisfied were coded as 2, 1, and 0, respectively. The satisfaction variable was formed by adding the scores from the eight questions; the range was from 0 (very dissatisfied) to 16 (totally satisfied).
Subjective assessment of complete denture retention	up to 6 months	Complete dentures for each subject will be subjectively evaluated for denture retention by the use of the scoring system described by Kapur. Each denture is scored on a scale from 0 to 6 based on clinical examination: The total score (0-6) is used to classify denture performance as: Clinically poor: \<6 Clinically fair: 6-8 Clinically good: \>8
Trueness of CAD/CAM monolithic dentures	Baseline (Day 1)	The CAD/CAM monolithic dentures will be scanned with laboratory scanner (Medit T710) . Data from the scans will be stored in a STL format. The scans of the conventional dentures will be considered the reference STL files. The scans of each denture base will be imported into an analytic software program. All the study denture file will be separated into cameo, and intaglio portions, according to the software program processing protocol. To determine the trueness (root mean square (RMS)), measured in mm of conventional and monolithic complete dentures, comparisons will be conducted for the cameo, and intaglio portions. All the study sample STL files will be superimposed to the corresponding reference STL files using voxel-based best-fit alignment in the surface matching software. Color maps will also be produced to demonstrate the qualitative three-dimensional differences between the test and reference files

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt