Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

NCT04475679 | Terminated Results

• 1 other identifier: LL3615088
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Defective Tooth Restorations

Keywords

caries; restoration

Outcome Measures

Primary Outcomes (2)

• FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5

  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"

  Baseline (7-10 days)

• FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5

  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"

  12 months

Secondary Outcomes (8)

• Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5

  Baseline

• FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5

  Baseline

• FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5

  Baseline

• FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5

  Baseline

• Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5

  12 months

Study Arms (2)

Adhese Universal DC

EXPERIMENTAL

Device: Adhese Universal DC

Adhese Universal

ACTIVE COMPARATOR

Device: Adhese Universal

Interventions

Adhese Universal DC DEVICE

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

Adhese Universal DC

Adhese Universal DEVICE

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

Adhese Universal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Ivoclar Vivadent

Schaan, 9494, Liechtenstein

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 17, 2020
• Study Start: September 14, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Locations

LI (1)