Clinical Study 3MESPE Crowns

Dental Caries Clinical Trial

Official title:

Clinical Pilot Study of: Astringent Retraction Paste, Imprint™ 4 VPS, Imprint 4™ Preliminary, Intra-oral Syringes, 3M ESPE New Temporary Restoration (SuPro 100 and Temporary Cement), RelyX™ Unicem™ 2 Automix Cement, Lava™ Plus Zirconia Crowns

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02735304
• Other study ID #: CR15/02 STH 18492
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2021

Study information

• Verified date: September 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study seeks to address four independent questions that are all part of the delivery of care associated with the provision of a single item of treatment; an indirect restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a crown requires a series of sequential clinical and laboratory stages stages:

1. Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be crowned. This will be used to enable the fabrication of the temporary crown after the tooth has been prepared. This is standard care and follows established clinical protocols.

2. Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space for the crown that will be fabricated to replace the missing structure.

3. Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will be made to fabricate the crown. To take the impression, the dentist will need to gently push the gums away from the tooth by fractions of a millimeter so that the margins of the preparation are clearly discernible.

4. Stage 4 - Provision of a temporary restoration that will provide satisfactory function for a limited period of time, until the definitive crown can be fitted. This temporary crown is designed to have a finite short-term durability and have an ease of manufacture and subsequent removal; hence the use of a specific cement that will enable this.

5. Stage 5 - Fitting of the definitive restoration. This is designed to be a durable restoration, with a mean life expectancy measured in years, but which is ultimately determined by a number of clinical, biological and patient specific parameters. Definitive restorations are fitted with cement designed to retain the crown in permanent manner.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in need of at least one full-coverage posterior restoration (crown) in a permanent premolar or molar.

• If two teeth in opposing arches are in need of a full-coverage posterior restoration (crown) only the tooth or teeth in one arch will be included in the study.

Exclusion Criteria:

• Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155 will not be enrolled.

• Patients with contraindications as described in the 'Instructions for Use' of the study materials

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Impression intervention
The 1st intervention will compare two clinical impression techniques The Innovation treatment arm will receive the innovation treatment first and then crossover to receive the standard clinical practice treatment. The standard clinical practice treatment will receive the standard clinical practice treatment first and then crossover to receive the innovation treatment.

Locations

Country	Name	City	State
United Kingdom	Sheffield NHS Trust	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	3M ESPE

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the predictability	Assessment of the predictability of results as a function of accuracy of the resulting model, the dentist's judgment on the quality of impression and the accuracy of fit of the definitive restoration (Lava™ Plus Zirconia crown). Predictability is defined as the frequency in which an adequate result is obtained in a consistent manner	48 months