Functional Evaluation for 3D Printed Complete Dentures

NCT07806669 | Completed

• 1 other identifier: N202410051
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Complete dentures have a long history and remain one of the principal treatment options for patients with complete edentulism. However, conventional fabrication involves a complex series of clinical and laboratory procedures, and the final prosthesis cannot be reproduced with complete accuracy. With recent advances in digital dentistry, integrating digital technologies into complete denture fabrication has become an important area of research. Current evidence indicates that digitally fabricated three-dimensional (3D)-printed complete dentures can reduce the number of clinical procedures and shorten treatment time. Nevertheless, clinical evidence comparing the performance of conventionally fabricated and digitally fabricated 3D-printed complete dentures remains limited. Therefore, this study aims to compare the advantages and disadvantages of these two types of complete dentures using various subjective and objective outcome measures after each participant has used both dentures for a specified period.

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

• 3D model analysis compare and Tissue surface adaptation

  he master casts and the intaglio surfaces of the corresponding definitive complete dentures will be scanned to generate STL files. Each denture scan will be superimposed on its corresponding master cast scan using 3D analysis software. The root mean square deviation between the two surfaces will be calculated in millimeters to assess and compare the dimensional accuracy of conventionally fabricated and 3D-printed complete dentures. A lower deviation indicates greater dimensional accuracy. The master casts produced from the conventional custom-tray impression and the closed-mouth impression will be scanned to generate STL files. The two tissue surfaces will be superimposed using 3D analysis software. The root mean square deviation between the surfaces will be calculated in millimeters to quantify the differences between the two impression techniques.

  Immediately after delivery and at the end of each 6-week intervention period

Secondary Outcomes (4)

• Maximum Occlusal Force

  Immediately after delivery and at the end of each 6-week intervention period

• Masticatory Performance

  Immediately after delivery and at the end of each 6-week intervention period

• Patient Satisfaction

  Immediately after delivery and at the end of each 6-week intervention period

• Oral Health-Related Quality of Life

  Immediately after delivery and at the end of each 6-week intervention period

Study Arms (2)

Conventional-to-Digital Sequence

EXPERIMENTAL

Participants will wear conventional complete dentures for six weeks, followed by 3D-printed complete dentures for six weeks.

Device: Conventionally Fabricated Complete Denture; Device: Digitally Fabricated 3D-Printed Complete Denture

Digital-to-Conventional Sequence

EXPERIMENTAL

Participants will wear 3D-printed complete dentures for six weeks, followed by conventional complete dentures for six weeks.

Device: Conventionally Fabricated Complete Denture; Device: Digitally Fabricated 3D-Printed Complete Denture

Interventions

Digitally Fabricated 3D-Printed Complete Denture DEVICE

articipants will receive maxillary and mandibular complete dentures fabricated using a digital workflow. Diagnostic casts will be scanned, and 3D-printed record bases and occlusion rims will be used to record the maxillomandibular relationship and obtain closed-mouth definitive impressions following border molding. The master casts and facial photographs will be digitized and used for computer-aided denture design. The definitive complete dentures will be fabricated using a 3D-printing system. Participants will wear the 3D-printed complete dentures for six weeks. Clinical adjustments will be performed 24 hours, three days, and one week after denture delivery. Subjective and objective outcome assessments will be conducted at the end of the six-week intervention period.

Conventional-to-Digital Sequence; Digital-to-Conventional Sequence

Conventionally Fabricated Complete Denture DEVICE

Participants will receive maxillary and mandibular complete dentures fabricated using a conventional workflow. The procedure includes preliminary alginate impressions, fabrication of custom impression trays, border molding, definitive impressions, recording of the maxillomandibular relationship, trial denture evaluation, and conventional flasking and heat-polymerization. Participants will wear the conventional complete dentures for six weeks. Clinical adjustments will be performed 24 hours, three days, and one week after denture delivery. Subjective and objective outcome assessments will be conducted at the end of the six-week intervention period.

Conventional-to-Digital Sequence; Digital-to-Conventional Sequence

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 20 years of age or older.
• Participants must be completely edentulous in both the maxilla and mandible, with at least three months having elapsed since the most recent tooth extraction.
• Participants must have sufficient cognitive ability to understand the study procedures and be able to read and complete the study questionnaires.
• Participants must voluntarily agree to participate in all study procedures after receiving and understanding the study information.

You may not qualify if:

• Individuals who are unable to read or complete the study questionnaires.
• Individuals with temporomandibular disorders that impair normal mouth opening and closing or prevent them from performing movements according to the investigators' instructions.
• Individuals with maxillary or mandibular defects resulting from congenital conditions or surgical procedures.
• Individuals whose physical or psychological health is considered unsuitable for study participation, as determined by the investigator or primary contact.

Sponsors & Collaborators

• Taipei Medical University: lead
• Sung Sang Corporation: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taipei, 110, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 8, 2026
• Study Start: February 14, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 5, 2025
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)