NCT07180732

Brief Summary

To evaluate the discrepancy between the digital smile design (DSD) and the resulting direct composite veneers via Injection Moulding Technique.

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 May 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 12, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

Injection mouldingVeneersAccuracyGeomagicresin composite

Outcome Measures

Primary Outcomes (1)

  • Accuracy

    The root mean square (RMS) values were obtained through the "3D-compare" method followed by comparison at each surface point between the reference digital design desing and the final outcome using injection moulding

    From enrolment to the end of treatment after 4 weeks

Study Arms (2)

Injection moudling technique

EXPERIMENTAL

A dental procedure where a patient-approved tooth shape, established from a diagnostic wax-up, is replicated using a transparent silicone index

Procedure: Injection moulding technique

Digital smile design

OTHER

Baseline smile design

Diagnostic Test: Digital smile design

Interventions

A dental technique that uses a transparent silicone index or stent to inject a low-viscosity composite into a pre-planned and approved tooth shape.

Injection moudling technique
Digital smile designDIAGNOSTIC_TEST

A modern approach that uses digital imaging, videos, and software to create a customized, virtual 3D model of a patient's ideal smile before any treatment begins

Digital smile design

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants requiring smile make-over
  • Good oral hygiene
  • Compliance

You may not qualify if:

  • Poor oral hygiene
  • Need for orthodontic treatment
  • Need of full coverage restoration
  • Parafunctional habits
  • Lack of compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of dentistry, Newgiza University

Cairo, 12577, Egypt

Location

Study Officials

  • Omar O Shaalan, PhD

    Associate Professor, Department of conservative dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of conservative dentistry

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

May 1, 2025

Primary Completion

August 31, 2025

Study Completion

September 10, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to concerns regarding participant privacy and the absence of explicit consent for data sharing

Locations