Clinical Evaluation of a New Dual-cure Universal Adhesive

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2031-04-30

Brief Summary

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The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.

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Detailed Description

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Conditions

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Class I Dental Restorations Class II Dental Restorations Insufficient Dental Restoration Caries, Dental

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New dual-cure adhesive

The newly developed dual-cure adhesive will be used for the placement of indirect restorations.

Group Type EXPERIMENTAL

Placement of indirect dental restoration

Intervention Type DEVICE

The newly developed dual-cure adhesive will be used for the placement of indirect restorations.

Interventions

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Placement of indirect dental restoration

The newly developed dual-cure adhesive will be used for the placement of indirect restorations.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 18-65 years
* Informed consent signed and understood by the subject
* Indication for indirect restorations (inlay, onlay) in molar or premolar
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* visual analogue scale (VAS)\<4 (0=no pain, 10=maximum conceivable pain)
* 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

* Insufficient isolation
* 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
* Tooth with irreversible pulpitis
* Indication for direct pulp capping
* Bleaching of teeth within the last 14 days
* Usage of peroxide-based disinfectants within the last 14 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No