Digital vs Conventional Prosthetic Rehab & Occlusal Analysis in Edentulous Patients

NCT07164066 | Not Yet Recruiting

• 1 other identifier: MBRU IRB-2024-374
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

15 Patients requiring complete dentures will be recruited from Dubai Health. Each patient will receive two sets of dentures with a washout period between sets. Patients will remain blinded to the fabrication method used for each set.

• Group 1: Participants will first receive conventionally fabricated dentures for both the upper and lower jaws. This set will be made using traditional techniques, including impressions, a custom tray, jaw relation recording, try-in, and final fitting. After the washout period, they will receive a second set created with the 3D-printed technique.
• Group 2: Participants in this group will initially receive 3D-printed complete dentures through a digital workflow, which involves intraoral scanning, STL file export, digital design, design review with the patient, 3D printing, and final fitting. Following the washout period, they will then receive a conventionally fabricated set.

Conditions

Edentulous Complete Denture Wearers; Dental Occlusion

Keywords

Edentulism; Digital Occlusal Analysis; Digital Dentures; Quality of life; Occlusion

Outcome Measures

Primary Outcomes (1)

• Occlusal Force Distribution and Contact Accuracy

  Quantitative assessment of occlusal contact number, area, timing, and force distribution in digital versus conventional complete dentures, measured using T-Scan and ModJaw systems, and validated against articulating paper marks.

  12 months

Secondary Outcomes (1)

• Oral Health-Related Quality of Life (OHRQoL)

  12 months

Other Outcomes (1)

• Clinical Time Efficiency

  12 months

Study Arms (2)

Conventional Dentures

OTHER

Participants will first receive conventionally fabricated dentures for both the upper and lower jaws. This set will be made using traditional techniques, including impressions, a custom tray, jaw relation recording, try-in, and final fitting. After the washout period, they will receive a second set created with the 3D-printed technique.

Device: Digital Occlusal Analysis Device

Digital Dentures

OTHER

Complete dentures fabricated with digital workflow, including intraoral scanning, CAD/CAM design, and 3D printing, followed by clinical fitting.

Device: Digital Occlusal Analysis Device

Interventions

Digital Occlusal Analysis Device DEVICE

Computerized occlusal analysis performed using T-Scan and ModJaw devices to record occlusal contacts, timing, and force distribution during prosthesis fitting and function.

Conventional Dentures; Digital Dentures

Eligibility Criteria

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

You may qualify if:

• Adults above the age of eighteen years seeking replacement of missing teeth
• Edentulous patients 6 months after extraction of any teeth
• Males and Females

You may not qualify if:

• Temporomandibular Joint Disorders(TMD)
• Limited mouth opening
• History of Head and neck oncology
• Conditions- such as Psychiatric conditions and Neurological conditions-, such as Parkinson's disease and Alzheimer's

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Related Publications (4)

• McKenna G, Tsakos G, Burke F, Brocklehurst P. Managing an Ageing Population: Challenging Oral Epidemiology. Prim Dent J. 2020 Sep;9(3):14-17. doi: 10.1177/2050168420943063.

  PMID: 32940594 BACKGROUND

• Muller F. Interventions for edentate elders--what is the evidence? Gerodontology. 2014 Feb;31 Suppl 1:44-51. doi: 10.1111/ger.12083.

  PMID: 24446979 BACKGROUND

• Qadeer S, Kerstein R, Kim RJ, Huh JB, Shin SW. Relationship between articulation paper mark size and percentage of force measured with computerized occlusal analysis. J Adv Prosthodont. 2012 Feb;4(1):7-12. doi: 10.4047/jap.2012.4.1.7. Epub 2012 Feb 29.

  PMID: 22439094 BACKGROUND

• Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.

  PMID: 21050499 BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Haitham Elbishari, PhD

  MBRU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

May Al Janahi, Dclident

CONTACT

+971507190034; may.aljanahi@dubaihealth.ae

Haitham Elbishari, PhD

CONTACT

+9714383; helbishari@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Prosthodontist

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 9, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share