Occlusal Adjustment Time and Volume for Single Unit Fixed Prosthesis Fabricated With Different Virtual Mounting

NCT05471024 | Completed DMC

• 1 other identifier: KADY0001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Regardless of the fabrication workflow occlusal adjustments seem to be inevitable during delivery of indirect fabrication of the restoration. This has been attributed to snowballing of discrepancies due to multiple procedures for information transfer between the clinician and the laboratory. Current digital workflows minimize these discrepancies due to digital acquisition technology which eliminates drawbacks from physical materials which would alter the dimensions and morphology of the final restoration. Utilizing 3D face scanning technology is by far the least invasive and the least time consuming of available virtual facebow techniques and thus it's utilization could offer the benefit of saving time during occlusal adjustment and enhanced strength of the restoration by not subjecting it to the heat generation and subsequent crack initiation which occurs during occlusal adjustment. This study aims to compare the effect of a face scan to alignment of the maxillary cast on the volume and time of occlusal adjustment compared to conventional articulator digitization to align the maxillary cast.

Conditions

Crowns; Dental Occlusion

Keywords

Occlusion; Occlusal Adjustment; Virtual Articulator; Occlusal Design; Occlusal Interference

Outcome Measures

Primary Outcomes (1)

• Clinical Occlusal Adjustment Time

  Time taken to harmonize occlusal contacts with participants masticatory function during delivery of the crown.Measured in minutes and seconds.

  Immediately after verification of restoration acceptability but prior to occlusal adjustment. Time will be measured until occlusal contacts of the crown have been harmonized during the delivery clinical visit.

Secondary Outcomes (1)

• Volume of Occlusal Adjustment

  Before and immediately after the occlusal adjustment. Volume before occlusal adjustment - volume after occlusal adjustment of the of the crown = volume difference

Study Arms (3)

Digitized Mounted Articulator Scan

ACTIVE COMPARATOR

Conventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.

Procedure: Digitized Mounted Articulator Scan

Average Positioning on Virtual Bonwill Triangle

EXPERIMENTAL

Virtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.

Procedure: Average Positioning on Virtual Bonwill Triangle

Digital Face Scan

EXPERIMENTAL

Digital face scan will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.

Procedure: Digital Face Scan

Interventions

Digitized Mounted Articulator Scan PROCEDURE

Conventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.

Digitized Mounted Articulator Scan

Average Positioning on Virtual Bonwill Triangle PROCEDURE

Virtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.

Average Positioning on Virtual Bonwill Triangle

Digital Face Scan PROCEDURE

Digital face scan will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.

Digital Face Scan

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged 21-70 years old, be able to read and sign the informed consent document.
• Psychologically and physically able to withstand conventional dental procedures.
• Participants with molars indicated for full coverage restorations
• Large carious lesions
• Teeth restored with large restorations
• Endodontically treated teeth
• Accept to undergo face scanning and articulator mounting procedures
• Have no active periodontal or pulpal diseases, have teeth with clinically acceptable restorations.
• Able to attend punctually for preplanned visits and evaluation.

You may not qualify if:

• Participants with active resistant periodontal diseases.
• Participants with poor oral hygiene, high caries risk and uncooperative participants.
• Pregnant women.
• Participants in the growth stage with partially erupted teeth.
• Psychiatric problems or unrealistic expectations.
• Lack of opposing dentition in the area of interest.
• Restored occlusal surface opposing the planned restoration.
• The presence of a removable or fixed orthodontic appliance.
• Signs of bruxism or clenching

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Aly AM El-Kady, MSc

  Fixed Prosthodontics Department, Misr International University

  PRINCIPAL INVESTIGATOR

• Shereen A Ameen, Prof. Dr.

  Fixed Prosthodontics Department, Cairo University

  STUDY CHAIR

• Rasha NM Sami, Prof. Dr.

  Fixed Prosthodontics Department, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All conventional and digital mounting procedures will be performed with all trial participants and the allocation will occur as to which mounting procedure will be utilized in the designing of the crown. Sequence allocation will be performed using a random sequence generated by an impartial third party who will assign an equal number of participants to each mounting condition. This allocation will be shared with the laboratory technician but not the main investigator as he will be performing the outcomes assessments.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of fixed prosthodontics

Model Details: Triple blind (participant, investigator and outcomes assessor), randomized, clinical superiority trial with 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 22, 2022
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 27, 2022
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)