Surface Hardness and Wear Characteristics of Prefabricated and CAD/CAM Milled Artificial Teeth

Surface Hardness and Wear Resistance of Prefabricated and CAD/CAM Milled Artificial Teeth: A Cross-over Clinical Study

Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and 2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated) and CAD/CAM milled artificial denture teeth.

material and methods: In a cross-over study design, ten completely edentulous patients were randomly chosen for this study and given two complete dentures. The first complete denture was constructed with pre-fabricated teeth. The second complete denture was constructed with CAD\CAM milled teeth. The complete denture teeth were 3D scanned at the time of insertion (T0), after three months (T3), and after six months (T6) of denture insertion. Utilizing 3D surface superimposition techniques, the vertical (2D wear), and Volumatic (3D wear) material loss were measured. The hardness of the teeth were evaluated at the time of denture insertion (T0) then after 6 months (T6) of denture insertion by Vickers hardness test. Statistical analysis was done using SPSS software. Paired groups were compared by paired t test. Significant difference was considered if P ≤ 0.05.

Study Overview

• Status: Completed
• Conditions: Surface Hardness and Wear Resistance of Artificial Teeth
• Intervention / Treatment: Other: surface hardness test for denture teeth; Other: wear resistance of denture teeth measurement

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

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Faculty of Dentistry, Mansoura Univeristy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• completely edentulous
• angle class I maxillomandibular relations

Exclusion Criteria:

• Angle's class II, III maxillomandibular relation
• systemic disease that affect the bone and soft tissue health

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: complete denture with prefabricated artificial teeth; complete denture constructed with prefabricated artificial teeth and inserted in the patient mouth to be used for 3, 6 months	Other: surface hardness test for denture teeth; surface hardness test of denture teeth at insertion then after 6 months of use; Other: wear resistance of denture teeth measurement; 2D, Vertical wear, 3D Volumetric wear were measured for denture teeth
Other: complete denture with CAD\CAM milled artificial teeth; complete denture constructed with CAD\CAM Milled artificial teeth and inserted in the patient mouth to be used for 3, 6 months	Other: surface hardness test for denture teeth; surface hardness test of denture teeth at insertion then after 6 months of use; Other: wear resistance of denture teeth measurement; 2D, Vertical wear, 3D Volumetric wear were measured for denture teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wear resistance of denture artificial teeth	2D, 3D wear of denture teeth were measured using denture scanning and superimposition of the sanning at insertion to that after 3, 6 months using Exocad soft ware	6 months after denture use
surface hardness of the denture artificial teeth	the measurement of surface hardness was done using Vickers's test. this measurements was done at insertion then after 6 months	6 months after denture use

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A11080622

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