3D Integration of Facial , Intraoral Scanning and CBCT on Patient Satisfaction and Occlusion of Temporary, Permanent Implant Supported Prosthesis

NCT06846372 | Active Not Recruiting DMC FDA Device

• 1 other identifier: A04012023RP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will aim to evaluate the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.

Conditions

Occlusal Analysis; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• occlusion of temporary and permanent full arch implant supported prosthesis constructed by digital workflow

  "through study completion, an average of 1 year"

Secondary Outcomes (1)

• patient satisfaction of temporary and permanent full arch implant supported prosthesis constructed by digital workflow using (vas score)

  "through study completion, an average of 1 year"

Study Arms (2)

Temporary full arch implant supported prosthesis.

ACTIVE COMPARATOR

full arch temporary implant supported prosthesis will be fabricated for the first group using PMMA material

Device: occluscence; Other: patient satisfaction

permanent full arch implant supported prosthesis.

ACTIVE COMPARATOR

Permanent full arch implant supported prosthesis will be fabricated for the second group from zirconia

Device: occluscence; Other: patient satisfaction

Interventions

occluscence DEVICE

The OccluSense handheld is a battery powered device which uses your local wireless network to transmit the recorded data to the OccluSense-iPad-App. The inductive charger provides wireless power transfer. Fully charged batteries allow up to 4 hours usage of the device.

Temporary full arch implant supported prosthesis.; permanent full arch implant supported prosthesis.

patient satisfaction OTHER

• patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent). Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?

Temporary full arch implant supported prosthesis.; permanent full arch implant supported prosthesis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy individuals with the completely edentulous maxilla and mandible rehabilitated by six implants.

You may not qualify if:

• individuals with uncontrolled systemic diseases that affect the success of implant survival rate

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry Mansoura university

Al Mansurah, Egypt

Location

Related Publications (1)

• Kuhlman DC, Almuzian M, Coppini C, Alzoubi EE. Accuracy (trueness and precision) of four tablet-based applications for three-dimensional facial scanning: An in-vitro study. J Dent. 2023 Aug;135:104533. doi: 10.1016/j.jdent.2023.104533. Epub 2023 May 4.

  PMID: 37149254 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mostafa Abdo El Syad, Professor

  faculty of dentistry Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: February 26, 2025
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)