Completed

Intraoral Scanner Accuracy with Cut-out-Rescan and Rubber-Dam Isolation

What is being tested

Taking images from the right lower jaw with an intraoral scanner

+ Clamp placement on canine and 2nd molar teeth and rubberdam rubber band insertion

DeviceProcedure

Who is being recruted

From 18 to 65 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: October 2024

See protocol details

Summary

Principal SponsorMarmara University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2024

Actual date on which the first participant was enrolled.

This study aims to evaluate the accuracy of four different intraoral scanners when using a specific procedure called "cut-out-rescan" under rubber dam isolation. The focus is on patients with good oral health who are undergoing routine dental treatments. The research seeks to understand how well these scanners can capture true representations of teeth, which is crucial for precise dental work. Accurate scans are important for creating dental restorations that fit perfectly, and this study could lead to improved outcomes in dental care by refining scanning techniques. Participants in the study have their lower teeth scanned using four different types of intraoral scanners. A rubber dam is used to isolate certain teeth, which helps to improve the scanning process. The study involves marking and trimming specific areas on the digital scan, then rescanning these areas to check for accuracy. The process is carefully controlled and compared using sophisticated software to measure any differences between the initial and final scans. The analysis involves various statistical methods to ensure the results are reliable, with the ultimate goal of determining which scanner provides the most accurate results. This could lead to better fitting dental appliances and more effective restorative treatments.

Official TitleThe Effect of "Cut-out-Rescan" Procedure Under Rubber-Dam Isolation on the Trueness of Intraoral Scanners

NCT06689384

Principal SponsorMarmara University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate

Caries in the right or left lower 2nd premolar tooth suitable for direct composite restoration indication

l8-65 age range

Have sufficient cognitive ability to understand the consent procedure

To have clinically healthy gingiva and periodontium

Show More Criteria

8 exclusion criteria prevent from participating

Any disability (mental health conditions, mental disabilities and physical disabilities)

Systemic diseases or medically serious risks (cardiovascular disorder, diabetes, hypertensive, epileptic)

Gingival hyperplasia or periodontal disease

Symptoms of periapical or pulpal pathology

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

20 patients with adequate oral health who had daily routine appointments for treatment at Marmara University restorative dentistry department were included in the study. Exclusion criteria for the study were missing premolar and molar teeth (except wisdom teeth) or the presence of amalgam and ceramic restorations that could affect the scanning in the right hemi-arc of the mandible. Using of intra oral scanners was performed by a restorative dentist with 5 years of experience. were scanned with 4 different intraoral scanners (IOS) (Trios 3, 3Shape; Primescan, Dentsply; Element 5D, iTero; Lumina, iTero) prior to the procedure, and the obtained digital impressions were stored as a standard tessellation language (STL) file. The digital scan had appropriate anatomic references to enable a proper matching with the digital scan taken after teeth preparation. The official scanning strategy and ambient scanning light conditions in the manufacturer's instructions were followed for all scanners.

Group II

Experimental

Subsequently, the mesh hole area was rescanned starting on the occlusal surface of the second molar, moving toward the occlusal of the first molar to the occlusal of the second premolar, then the buccal surfaces of the second premolar, followed by the first molar and second molar. The rescanning procedures ended with the lingual surfaces of the second molar, followed by the lingual surfaces of the first molar and second premolar. Following the second scan, the area was re-scanned in high-resolution mode, where higher mesh quality could be achieved. The software of the intraoral scanner automatically fused two different data sets obtained by initial/reference and preparation digital scans. Data about tooth positions, morphologies, rubber dam, and surrounding soft tissues was integrated simultaneously. The obtained final scan was exported as an STL file.

Group III

Experimental

In the procedure that simulated the final impression process under rubber dam isolation, the relevant tooth was marked on the initial scan along with the contact areas of the adjacent teeth. The marked area which the to be re-scanned, was trimmed away from the virtual casts. The diameter of the mesh holes was controlled by adjusting the settings of the automatic mesh hole generator in the software program of the IOS.

Group IV

Experimental

The 2nd premolar, 1st, and 2nd molar teeth were isolated with a rubber dam (medium; Nic Tone, Manufacturera Dental Continental) to be included in the operation field. Clamps were placed on the 2nd premolar and 2nd molar teeth. It was aimed to facilitate the second scanning process by expanding the isolation area to include 3 teeth. A flowable composite was applied by placing Teflon tape on the occlusal surface of the 1st molar to create a difference in its morphology. In the procedure that simulated the final impression process under rubber dam isolation, the relevant tooth was marked on the initial scan along with the contact areas of the adjacent teeth. The marked area which the to be re-scanned, was trimmed away from the virtual casts. The diameter of the mesh holes was controlled by adjusting the settings of the automatic mesh hole generator in the software program of the IOS.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Marmara University Faculty of Dentistry

Istanbul, Turkey (Türkiye)Open Marmara University Faculty of Dentistry in Google Maps

CompletedOne Study Center