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Clinical Study Class II on Ceram.x Universal and Prime&Bond

Primary Purpose

Dental Caries

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Prime & Bond Universal

Ceram X

Prime & Bond XP

technique 1

technique 2

About this trial

This is an interventional other trial for Dental Caries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria for patient selection:

Patients of either gender and at least 18 years old at the start of the study (enrollment), who are seeking treatment at the dental clinic involved, will be invited to participate in the study if they are in need of at least one eligible Class II posterior restoration in a permanent molar.

Tooth inclusion criteria:

Per patient, a maximum of three Class II restorations will be included. If three restorations are indicated and eligible, one of each material will be included.
Vital, non-symptomatic permanent teeth with Class II lesions are suitable for inclusion into the study if the following criteria are met:
- - location: first or second molars (ADA guidelines[1]);
- - restoration size: moderate: no cusp replacements;
- - cavity size: occlusal width ≥ 1/3 of intercuspal distance (ADA guidelines[1]);
- - cavity outline: preparation to include a proximal box with or without an occlusal step;
- - box: cervical outline in enamel;
- - occlusion: at least one opposing contact point in enamel.
Enrollment of patients will continue until the specified minimum number of restorations per group (N=25) and/or the minimum number of patients (N=50) have been reached.

Exclusion Criteria:

Exclusion criteria for patient selection:

The exclusion criteria (i.e. contraindications) as described in the Instructions for Use of the test, control and restorative materials apply:
Use with patients who have a history of severe allergic reaction methacrylate resins or any of the components; direct application to dental pulp (direct pulp capping).
Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155[4] will not be enrolled.

Tooth exclusion criteria:

As a rule, the materials are not to be used in situations as specified in the Instructions for Use - Section Contraindications.

direct or indirect pulp-capping Furthermore, teeth with class II lesions are excluded when involved with
inflammation or pulpitis (pain),
periodontitis with probing depth > 6 mm,
extraction of tooth to be expected within the next 12 months,
signs of strong parafunctions or erosion (exposed dentin on occlusal surface and/or wear facets > 6 mm2)

Sites / Locations

Professor Nicolas Martin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

existing adhesive (control)

new adhesive: technique 1

new adhesive: technique 2

Arm Description

control adhesive

Prime & Bond Universal: technique 1

Prime & Bond Universal: technique 2

Outcomes

Primary Outcome Measures

Number of participants with treatment-related postoperative sensitivity recorded as a change from baseline to that reported at 14 days, 6 months, 12 months and 48 months, assessed using a visual analog scale.

Secondary Outcome Measures

Full Information

NCT ID

NCT02991573

First Posted

December 4, 2015

Last Updated

September 10, 2019

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Dentsply International

1. Study Identification

Unique Protocol Identification Number

NCT02991573

Brief Title

Clinical Study Class II on Ceram.x Universal and Prime&Bond

Official Title

Clinical Post-Market Surveillance Study of Ceram.x Universal and Prime&Bond Universal When Used for Class II Restorations at the University of Sheffield

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Dentsply International

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Damage to teeth from decay or previous old silver fillings can be repaired with tooth-coloured filling materials that stick to the tooth. These materials have been around for some years and have become more sophisticated; with greater ease of placement by the dentist and better durability for the patient. The fillings are designed to be used in combination with a specific glue (adhesive) that is designed to stick to the different parts of the tooth to provide a good seal, the outer enamel and the inner dentine. This study will examine the performance of a state-of-the-art modern tooth coloured filling material (Ceram X) in combination with an existing adhesive (control adhesive) and a new adhesive (Prime & Bond Universal) used in two different techniques; both of which are known to work but one is easier to apply. This results in three treatment groups. At the start of the study, the test material Prime&Bond Universal is CE-marked, as are all other medical devices used. Thus, this study is not conducted to meet any regulatory requirements. The rationale of this study is the extension of knowledge primarily concerning the clinical performance of Prime&Bond Universal in molars. Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75 restorations in total) to assess the performance of the materials in a comparative design. The study restorations will be monitored for a period of 18 months (with the option to extend the evaluation period to 48 months). After placement of restorations under controlled clinical conditions, the primary objective of the study is the determination of post-operative sensitivity and pulp vitality, marginal adaptation and staining of margins of the restorations. In addition, fracture of material and retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be determined as well as the failure rate as defined by the ADA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

existing adhesive (control)

Arm Type

Active Comparator

Arm Description

control adhesive

Arm Title

new adhesive: technique 1

Arm Type

Experimental

Arm Description

Prime & Bond Universal: technique 1

Arm Title

new adhesive: technique 2

Arm Type

Experimental

Arm Description

Prime & Bond Universal: technique 2

Intervention Type

Device

Intervention Name(s)

Prime & Bond Universal

Intervention Description

Prime & Bond Universal

Intervention Type

Device

Intervention Name(s)

Ceram X

Intervention Type

Device

Intervention Name(s)

Prime & Bond XP

Intervention Description

Control

Intervention Type

Procedure

Intervention Name(s)

technique 1

Intervention Type

Procedure

Intervention Name(s)

technique 2

Primary Outcome Measure Information:

Title

Time Frame

14 days, 6 months, 12 months and 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion criteria for patient selection: Patients of either gender and at least 18 years old at the start of the study (enrollment), who are seeking treatment at the dental clinic involved, will be invited to participate in the study if they are in need of at least one eligible Class II posterior restoration in a permanent molar. Tooth inclusion criteria: Per patient, a maximum of three Class II restorations will be included. If three restorations are indicated and eligible, one of each material will be included. Vital, non-symptomatic permanent teeth with Class II lesions are suitable for inclusion into the study if the following criteria are met: - location: first or second molars (ADA guidelines[1]); - restoration size: moderate: no cusp replacements; - cavity size: occlusal width ≥ 1/3 of intercuspal distance (ADA guidelines[1]); - cavity outline: preparation to include a proximal box with or without an occlusal step; - box: cervical outline in enamel; - occlusion: at least one opposing contact point in enamel. Enrollment of patients will continue until the specified minimum number of restorations per group (N=25) and/or the minimum number of patients (N=50) have been reached. Exclusion Criteria: Exclusion criteria for patient selection: The exclusion criteria (i.e. contraindications) as described in the Instructions for Use of the test, control and restorative materials apply: Use with patients who have a history of severe allergic reaction methacrylate resins or any of the components; direct application to dental pulp (direct pulp capping). Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155[4] will not be enrolled. Tooth exclusion criteria: As a rule, the materials are not to be used in situations as specified in the Instructions for Use - Section Contraindications. direct or indirect pulp-capping Furthermore, teeth with class II lesions are excluded when involved with inflammation or pulpitis (pain), periodontitis with probing depth > 6 mm, extraction of tooth to be expected within the next 12 months, signs of strong parafunctions or erosion (exposed dentin on occlusal surface and/or wear facets > 6 mm2)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Martin, Professor

Organizational Affiliation

Sheffield Teaching Hospitals NHS FT

Official's Role

Principal Investigator

Facility Information:

Facility Name

Professor Nicolas Martin

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2TA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Study Class II on Ceram.x Universal and Prime&Bond

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