3D Facial Scanning in Full-Arch Implant Prosthodontics: Time Efficiency and Patient Satisfaction

NCT07751900 | Completed

• 1 other identifier: FDASU-Rec IR/M102515
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two ways of planning the bite (jaw-relation) stage of full-arch, implant-supported dental prosthesis treatment: a standard digital approach, and the same approach with the addition of 3D facial scanning, which lets the dental team plan the new teeth against a scan of the patient's own face. The study measured how patients felt about their treatment using a validated questionnaire, and also tracked how many clinic visits and adjustments each approach needed. Twenty-two patients took part, randomly assigned to one of the two approaches.

Conditions

Full-Arch Edentulism; Maxillofacial Prosthesis; Dental Implant-Supported Prosthesis

Keywords

3D facial scanning; digital workflow; jaw-relation recording; full-arch rehabilitation; dental implants; OHIP-14; patient-reported outcomes; time efficiency

Outcome Measures

Primary Outcomes (2)

• Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint

  Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse). Assessed after the patient had worn the try-in (trial) prosthesis intraorally for four weeks (T1).

  4 weeks

• Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint

  Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse). Assessed four weeks after delivery of the definitive prosthesis (T2).

  4 weeks

Secondary Outcomes (3)

• Number of Clinical Appointments to Complete the Prosthetic Phase

  up to 12 weeks

• Number of Try-In Adjustments

  up to 8 weeks

• Implant and Prosthesis Survival / Complications at 6 Months

  6 months post-delivery

Study Arms (2)

Conventional-Digital Hybrid Workflow

ACTIVE COMPARATOR

aw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, without facial scanning.

Procedure: Conventional-Digital Jaw-Relation Workflow

Enhanced Digital Workflow with 3D Facial Scanning

EXPERIMENTAL

Same base digital workflow as Group A, with the addition of high-resolution 3D facial scanning (Shining 3D structured-light scanner), merged with intraoral scans and CBCT data via Exocad software to guide prosthetic alignment against extraoral facial landmarks.

Procedure: 3D Facial Scanning-Guided Jaw-Relation Workflow

Interventions

Conventional-Digital Jaw-Relation Workflow PROCEDURE

Jaw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, w

Conventional-Digital Hybrid Workflow

3D Facial Scanning-Guided Jaw-Relation Workflow PROCEDURE

Integration of 3D facial scanning into the jaw-relation recording stage of full-arch implant prosthetic rehabilitation, merging facial, intraoral, and CBCT datasets to guide prosthetic design against facial reference planes. Performed in addition to the same base digital workflow described in Intervention 1.

Enhanced Digital Workflow with 3D Facial Scanning

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) indicated for full-arch maxillary implant-supported fixed prosthetic rehabilitation
• Completion of the surgical phase with stable implant osseointegration
• Presence of healthy peri-implant soft tissues
• Adequate oral hygiene status
• Sufficient bone and soft-tissue conditions compatible with full-arch prosthetic rehabilitation
• Ability to comply with all scheduled follow-up visits
• Capacity to maintain natural head position during facial scanning procedures
• Absence of significant gag reflex interfering with scanning/impression procedures
• Ability to communicate effectively and complete questionnaires
• Provision of written informed consent
• Physically and psychologically fit for the planned treatment

You may not qualify if:

• Severe skeletal or orthognathic discrepancies
• History of significant facial trauma or surgery affecting facial symmetry
• Prior maxillofacial pathology affecting the surgical/prosthetic site
• Uncontrolled systemic diseases affecting healing or treatment tolerance
• Use of medications that alter osseointegration or facial soft tissues
• Active oral or peri-implant infection
• Neuromuscular disorders or temporomandibular joint dysfunction affecting jaw positioning
• Conditions affecting the ability to maintain stable head position for scanning
• Severe psychomotor limitations
• Known hypersensitivity to materials used in bite registration or prosthesis fabrication
• Inability or unwillingness to provide informed consent
• Pregnancy or lactation, if deemed a contraindication by the supervising clinician
• Poor compliance or demonstrated unreliability in past dental or medical care

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 7, 2026
• Study Start: October 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: July 25, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)