Clinical Study 3MESPE Crowns

NCT ID: NCT02735304

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-07-31

Brief 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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Innovation treatment 3M ESPE materials

The Innovation treatment arm will receive the innovation treatment first and then crossover to receive the standard clinical practice treatment during the Impression intervention.

Materials to be used all 3M ESPE - Astringent Retraction Paste, Imprint™ 4 Preliminary, Imprint™4 VPS, Imprint™ 4 Bite, Intra-oral syringes, Impression Tray,

Group Type: OTHER

Impression intervention

Intervention Type: OTHER

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.

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 during the Impression intervention

Materials as per the operating dentist's choice to be recorded on CRF

Group Type: OTHER

Impression intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3M ESPE

INDUSTRY

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Martin, Professor

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS FT

Locations

Sheffield NHS Trust

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR15/02 STH 18492

Identifier Type: -

Identifier Source: org_study_id