Comparison of Scanning With and Without Rubber Dam for Overlay Restorations

NCT05735509 | Completed DMC

• 1 other identifier: REST-ECL-2023-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The use of rubber dam when performing adhesive restorations improves the quality of the treatment. The widespread use of this type of restorations makes it increasingly necessary to use this type of isolation of the operative field. At the same time, the use of CAD/CAM systems in dentistry has recently become more widespread, which means that chairside systems are being used more and more frequently. Given that in indirect restorations it is necessary to place the rubber dam at the time of cementation, it has been proposed to take optical impressions of the preparation with the rubber dam already in place. For this it is necessary to have previous records that are cut out and rescanned. Since there are authors who have described that rescanning can cause defects in the meshes, in this work we try to compare both types of scanning in a specific type of restorations, the overlays. For this purpose, scans of the tooth preparation with and without rubber dam are taken, and a random decision is made on the basis of which scan the restoration is made. Then it is taken to the mouth and the marginal fit, contact points and occlusion of the restoration are evaluated. The results of the group made from the scan without dam are compared with those of the group made from the scan with dam. The two scans of each case are also compared to evaluate the differences.

Conditions

Crowns

Outcome Measures

Primary Outcomes (4)

• overall result of final crown

  The final crown is judged by the care provider. A 10 cm Visual analogue scale (VAS) is used. 0 (unacceptable) is placed in left end, and 10 (perfect) is placed in the right end.

  One day

• Marginal fit of final crown

  Marginal fit will be assessed with an exploratory probe under x3.50 magnification, observing the existence of marginal fit in mesial, distal, buccal, and lingual surfaces. The probe used will be a #23/6 explorer which measures 0.22 mm at 1 mm from the tip. A score of 0 (no perception of the gap when probing), 1 (tip of the probe slightly entered the gap), and 2 (the tip clearly entered the gap) will be used

  One day

• Contact points fit

  Interproximal contact points will be assessed with waxed dental floss. A score of 0 (incorrect contact point), 1 (correct contact point) will be used

  One day

• Occlusal adjustment

  Occlusal contacts will be verified with Bausch Arti-Check Micro-Thin 40μ articulating paper and Arti-Fol Metallic Shimstock-Film 12 μ. A score of 0 (no occlusal contacts), 1 (correct occlusal contacts) and 2 (too high occlusal contacts) will be used.

  One day

Study Arms (2)

Before rubber dam

ACTIVE COMPARATOR

Impression taken before rubber dam placement is used for crown manufacturing

Device: Rubber dam

After rubber dam

EXPERIMENTAL

Impression taken after rubber dam placement is used for crown manufacturing

Device: Rubber dam

Interventions

Rubber dam DEVICE

Intraoral impressions can be taken with rubber dam in place. The care provider will take two impressions, one with the rubber dam in place and one without. The investigator will randomly chose one of the two impressions for crown manufacturing, and the crown will be delivered by the care provider blindly

After rubber dam; Before rubber dam

Eligibility Criteria

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

You may qualify if:

• Need of an overlay restoration

You may not qualify if:

• No need of overlay restoration

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Clinica Universitaria d'Odontologia

Sant Cugat Del Vallés, Barcelona, 08195, Spain

Location

Related Publications (2)

• Henarejos-Domingo V, Clavijo V, Blasi A, Madeira S, Roig M. Digital scanning under rubber dam: An innovative method for making definitive impressions in fixed prosthodontics. J Esthet Restor Dent. 2021 Oct;33(7):976-981. doi: 10.1111/jerd.12787. Epub 2021 May 18.

  PMID: 34008328 BACKGROUND

• Espona J, Roig E, Ali A, Vidal C, Garcia-Font M, Roig M, Figueras O. Optical impressions assessment for overlay restorations with rubber dam: A clinical trial. J Dent. 2024 Apr;143:104825. doi: 10.1016/j.jdent.2023.104825. Epub 2023 Dec 28.

  PMID: 38157974 DERIVED

MeSH Terms

Interventions

Rubber Dams

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Equipment and Supplies

Study Officials

• José Espona, DDS

  Universidad Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The caree provider takes two impressions and the investigator selects one of them for crown manufacturing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Tooth to be restored are randomly assigned to on of two groups. In one impressions are taken before placing the rubber dam and in the second impressions are taken after placing the rubber dam.

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 21, 2023
• Study Start: January 30, 2023
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)