Cut-out-Rescan Procedure Under Different Rubber-Dam Isolation

NCT06893263 | Completed

• 1 other identifier: 09.2025.25-0128
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This clinical study investigated the effect of the "cut-out-rescan" procedure under different rubber dam isolation (blue and black) on restorative scanning trueness of two intraoral scanners. Materials and Methods: The initial scans were collected from 20 patients using two dental intraoral scanners (Cerec Primescan, Dentsply Sirona; iTero Element 5D, Align). The 3-dimensional data was obtained from the right or left side of the mandibula between the canine-to-2nd molar area and recorded in .stl format. Then the 2nd premolar was cut with the cutting tool in the related scanner software in a range including 1mm from the adjacent teeth. The determined area was clinically isolated with the rubber-dam and the same quadrant was rescanned to let the software overlap with the cut-out area. In one of the separate appointment sessions given for the treatment of the patient's decayed teeth in this area, this procedure was performed with a blue rubber dam isolation, and in the other, with a black rubber dam isolation.The overlapped scan was recorded in .stl format as the second scan data. The first and second scan data from the 4 scanners were then transferred to the Oracheck (Dentsply Sirona) software program and digitally overlapped to measure the conformity. The deviations detected in the 1st premolar, 2nd premolar, and 1st molar were selectively and jointly assessed in distance (mm) and volume (mm3) for every scanner data. Robust ANOVA and Kruskal Wallis tests were used for the statistical analyses and the significance level was set at \<.050.

Conditions

Trueness; Intraoral Scanner; Rubberdam; Color

Keywords

trueness; intraoral scanner; rubberdam; cut-out-rescan; color; indirect restoration

Outcome Measures

Primary Outcomes (6)

• Recording diagnostic 3D-image with Primescan intraoral scanner

  The diagnostic (first) 3D images were taken with Primescan from the right mandible of the patients. With the camera-containing tip of the intraoral scanner, the 3D image of the patient's right mandible was saved in the scanner's memory and can be examined in 3D in STL format on the computer screen. The scanners record multiple photographs while travelling through the patient's mouth with the camera and automatically combine them with the software to obtain a three-dimensional image

  up to 5 days

• Recording diagnostic 3D-image with Itero Element 5D intraoral scanner

  The diagnostic (first) 3D images were taken with Element 5D from the right mandible of the patients. With the camera-containing tip of the intraoral scanner, the 3D image of the patient's right mandible was saved in the scanner's memory and can be examined in 3D in STL format on the computer screen. The scanners record multiple photographs while travelling through the patient's mouth with the camera and automatically combine them with the software to obtain a three-dimensional image

  up to 5 days

• Applying blue rubberdam isolation to patients

  On the 3rd and 7th teeth, rubber dam isolation was applied by placing a clamp. Threads were not involved during retraction. Only the gums were covered with rubber dam rubber and the teeth remained exposed.

  up to 5 days

• Applying black rubberdam isolation to patients

  On the 3rd and 7th teeth, rubber dam isolation was applied by placing a clamp. Threads were not involved during retraction. Only the gums were covered with rubber dam rubber and the teeth remained exposed.

  up to 5 days

• Selective cutting from image on Primescan intraoral scanner

  Using the computer software of the Primescan intraoral scanner and editing the screen of the scanner, the entire tooth number 5 in the 3D image and 1 mm of the adjacent teeth 4 and 6 were cut out

  up to 5 days

• Selective cutting from image on Itero Element 5D intraoral scanner

  Using the computer software of the Element 5D intraoral scanner and editing the screen of the scanner, the entire tooth number 5 in the 3D image and 1 mm of the adjacent teeth 4 and 6 were cut out

  up to 5 days

Secondary Outcomes (5)

• Recording final image with Primescan intraoral scanner

  up to 5 days

• Recording final image with Itero Element 5D intraoral scanner

  up to 5 days

• Registration of diagnostic and final 3D images obtained from Primescan scanner

  between days 5 and 10

• Registration of diagnostic and final 3D images obtained from Itero Element 5D scanner

  between days 5 and 10

• Statistical Analysis

  between days 10 and 15 (last 5 days of study)

Study Arms (4)

Recording of the diagnostic 3D images

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) ( Primescan, Dentsply; Element 5D) 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.

Device: Taking images from the right lower jaw with an intraoral scanner

Rubberdam Isolation

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. 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. This stage was repeated in 2 different treatment sessions, blue rubber dam was preferred in one of the appointments and black rubber dam was preferred in the other.

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

Recording the Final 3D Image

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.

Device: Taking images from the right lower jaw with an intraoral scanner

Selective Cutting on the Scanner

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.

Device: Taking images from the right lower jaw with an intraoral scanner

Interventions

Taking images from the right lower jaw with an intraoral scanner DEVICE

The patients' mandibular arches were scanned with 4 different intraoral scanners (IOS) (Primescan, Dentsply; Element 5D) prior to the procedure, and the obtained digital impressions were stored as a standard tessellation language (STL) file.

Recording of the diagnostic 3D images

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

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 canine 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.This stage was repeated in 2 different treatment sessions, blue rubber dam was preferred in one of the appointments and black rubber dam was preferred in the other.

Rubberdam Isolation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• l8-65 age range
• Have sufficient cognitive ability to understand the consent procedure
• To have clinically healthy gingiva and periodontium
• Daily cigarette consumption of 10 cigarettes or less
• No loss of attachment, bleeding or plaque accumulation on probing
• Vital mandibular teeth without signs of irreversible pulpitis
• Caries in the right or left lower 2nd premolar tooth suitable for direct composite restoration indication
• The 1st molar, 2nd molar, 1st premolar and canine teeth in the relevant region are not missing and do not contain any fixed prosthesis

You may not qualify if:

• 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
• Non-vital endodontically treated teeth
• Teeth showing mobility
• Congenital tooth deficiencies
• Having a prominent crossbite, missing teeth, jaw anomaly or prosthetic restoration in the relevant region

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Study Officials

• Bora Korkut, Associate Professor

  Marmara University

  PRINCIPAL INVESTIGATOR

• Ayşe Aslı Şenol, Asisstant Professor

  Marmara University

  STUDY DIRECTOR

• Cevdet Can Saygılı, Research assistant

  Marmara University

  PRINCIPAL INVESTIGATOR

• Bengü Doğu Kaya, Asisstant Professor

  Çanakkale Onsekiz Mart Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: February 24, 2025
• Primary Completion: February 28, 2025
• Study Completion: March 14, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TU (1)