Accuracy of Injection Moulding Technique

September 12, 2025 updated by: Omar Shaalan, NewGiza University

Accuracy of Direct Composite Veneers Using Injection Moulding Technique

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be aiming at testing the accuracy of the injection moulding technique compared with the digital smile design, therefore improving the outcome of composite veneers for the patients in order to reach more predictable results. Utilizing a quantitative method to assess accuracy of Injection moulding technique is deficient in literature and using a geometrical subtraction software will be an objective method to compare the difference with the digital smile design.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12577
        • School of dentistry, Newgiza University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection moudling technique
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
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.
Other: Digital smile design
Baseline smile design
Diagnostic test: Digital smile design
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: From enrolment to the end of treatment after 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NewGiza University

Investigators

  • Principal Investigator: Omar O Shaalan, PhD, Associate Professor, Department of conservative dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

September 12, 2025

First Submitted That Met QC Criteria

September 12, 2025

First Posted (Estimated)

September 18, 2025

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Accuracy of injection mouldong

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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