Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Sponsor

Ivoclar Vivadent AG (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04475679

Collaborator

(none)

Enrollment

Location

Arms

75.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Defective Tooth Restorations	Device: Adhese Universal DC Device: Adhese Universal	N/A

Detailed Description

This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth vitality and failure rate of placed restorations. Tooth vitality is an indicator for the health status of the dental pulp. A vitality test is performed to acquire information about the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test. Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the vitality test.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial

Actual Study Start Date :

Sep 4, 2020

Actual Primary Completion Date :

Jul 12, 2021

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adhese Universal DC	Device: Adhese Universal DC Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface
Active Comparator: Adhese Universal	Device: Adhese Universal Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth

Arm

Intervention/Treatment

Experimental: Adhese Universal DC

Device: Adhese Universal DC

Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface

Active Comparator: Adhese Universal

Device: Adhese Universal

Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth

Outcome Measures

Primary Outcome Measures

postoperative hypersensitivity [Baseline to 60 months]
assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Secondary Outcome Measures

loss of vitality of restored teeth [Baseline to 60 months]
assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
fracture rate of restored teeth [Baseline to 60 months]
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
retention/fracture rate of restorations [Baseline to 60 months]
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
marginal quality [Baseline to 60 months]
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 18-65 years
Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
2-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
Max. 2 restorations per participant in different quadrants.
Vital tooth
Healthy periodontium, no active periodontitis
Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
Sufficient language skills

Exclusion Criteria:

Sufficient isolation not possible, dry working field cannot be guaranteed
Participants with a proven allergy to one of the ingredients of the materials used
Participants with proven allergy to local anaesthetics
High caries activity/ poor oral hygiene
Participants with severe systemic diseases
Pregnancy
Nonvital tooth or tooth with irreversible pulpitis
Indication for direct pulp capping
Symptoms of SARS-CoV2 infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ivoclar Vivadent	Schaan		Liechtenstein	9494

Sponsors and Collaborators

Ivoclar Vivadent AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ivoclar Vivadent AG

ClinicalTrials.gov Identifier:

NCT04475679

Other Study ID Numbers:

LL3615088

First Posted:

Jul 17, 2020

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ivoclar Vivadent AG

caries

restoration

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Apr 11, 2022