NCT06666907

Brief Summary

The study aims to assess the accuracy and patient satisfaction of smile designs based on artificial intelligence versus conventional DSD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

October 27, 2024

Last Update Submit

June 6, 2025

Conditions

Esthetics, Dental

Keywords

Artificial intelligenceAccuracySmile DesignPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Accuracy

    Mean difference between the two designs measured in millimeters (mm) using geomagic control software.

    immediately after the procedure

Secondary Outcomes (1)

  • Patient satisfaction

    immediately after the procedure

Study Arms (2)

AI smile design

EXPERIMENTAL

Artificial intelligence digital smile designing software

Device: Smilefy

Conventional smile design

ACTIVE COMPARATOR

Digital smile design software

Device: EXOCAD

Interventions

SmilefyDEVICE

AI based DSD

AI smile design
EXOCADDEVICE

Conventional DSD software

Conventional smile design

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with esthetic problems that require digital smile design.
  • Patient's age ranging from 19-30
  • Good oral hygiene.
  • Patients who have stable occlusion.

You may not qualify if:

  • Poor oral hygiene.
  • Patients with high caries or high plaque index.
  • Patients with periodontal problems.
  • Heavy bruxism habit or presence of any parafunctional habits.
  • Pregnant or lactating women.
  • Participating in another trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Conservative Dentistry

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 31, 2024

Study Start

December 1, 2024

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Locations

EG(1)