Clinical Evaluation of OBU When Used for Indirect Dental Restorations

NCT06002880 | Terminated FDA Device

• 1 other identifier: Kerr 04-2022
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the clinical safety and performance of Optibond Universal (OBU), a single component universal dental adhesive intended for indirect dental restorations according to manufacturer's Instruction For Use.

Conditions

Sensitivity, Tooth

Outcome Measures

Primary Outcomes (11)

• Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)

  Preoperative sensitivity

  Screening

• Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)

  Preoperative sensitivity

  Preparation, Provisional Restoration (up to 6 weeks from Screening)

• Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)

  Postoperative sensitivity

  48 hours after Cementation (up to 4 weeks from Preparation)

• Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)

  Postoperative sensitivity

  Baseline Followup Assessments (approximately 3 weeks from Cementation)

• Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)

  Postoperative sensitivity

  6-months Followup Assessments (approximately 6 months from Baseline)

• Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)

  Postoperative sensitivity

  1-year Followup Assessments (approximately 1 year from Baseline)

• Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)

  Postoperative sensitivity

  2-Year Followup Assessments (approximately 2 years from Baseline)

• FDI (World Dental Federation) Clinical Evaluation Criteria-Modified

  Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)

  Baseline Followup Assessments

• FDI (World Dental Federation) Clinical Evaluation Criteria-Modified

  Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)

  6-months Followup Assessments

• FDI (World Dental Federation) Clinical Evaluation Criteria-Modified

  Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)

  1-year Followup Assessments

• FDI (World Dental Federation) Clinical Evaluation Criteria-Modified

  Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)

  2-Year Followup Assessments

Study Arms (8)

Post/Core-Total Etch

EXPERIMENTAL

Endodontic posts and/or cores-Total etch

Device: Optibond Universal

Ceramic-Total Etch

EXPERIMENTAL

Glass-ceramics-Total etch

Device: Optibond Universal

Metal/Zi-Total Etch

EXPERIMENTAL

Metal-Zi-Total etch

Device: Optibond Universal

Composite-Total Etch

EXPERIMENTAL

Composite-Total etch

Device: Optibond Universal

Post/Core-Self Etch

EXPERIMENTAL

Endodontic posts and/or cores-Self etch

Device: Optibond Universal

Ceramic-Self Etch

EXPERIMENTAL

Glass-ceramics-Self etch

Device: Optibond Universal

Metal/Zi-Self Etch

EXPERIMENTAL

Metal-Zi-Self etch

Device: Optibond Universal

Composite-Self Etch

EXPERIMENTAL

Composite-Self etch

Device: Optibond Universal

Interventions

Optibond Universal DEVICE

OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.

Ceramic-Self Etch; Ceramic-Total Etch; Composite-Self Etch; Composite-Total Etch; Metal/Zi-Self Etch; Metal/Zi-Total Etch; Post/Core-Self Etch; Post/Core-Total Etch

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is willing to provide voluntary written informed consent in English.
• Is in good medical health and able to tolerate the dental procedures.
• Has 1 qualifying either vital or endodontically treated molar and/or premolar that requires an endodontic post and or core build-ups with subsequent indirect restoration or an indirect restoration only. Only 1 tooth per quadrant can be included in the study if more than 1 tooth in need of restoration. The maximum number of restorations will not exceed two per patient.
• The tooth must be restorable, i.e. without subgingival caries and must have a minimum of 2-3 mm healthy supragingival tooth structure.
• Study teeth must have an antagonist in the opposite jaw and have a neighboring tooth on at least one side.
• Study teeth must be vital and without any symptoms suggesting irreversible damage of the pulp, or endodontically treated and hermetically filled according to standards of care (i.e., free of clinical signs and symptoms of periapical pathology).

You may not qualify if:

• Is currently taking part in an evaluation of other dental procedures.
• Has chronic periodontitis or rampant caries.
• The study tooth exhibits clinical signs of periapical pathology.
• The study tooth has a history of self-reported preoperative pulpal problems.
• The study tooth that has been restored using eugenol containing materials.
• Study Subjects with severe parafunctional habits or occlusal issues affecting the subject teeth.
• Women who are pregnant (self-reported). It is standard of care to postpone routine dental procedures and radiographed until after pregnancy.
• Women who are breast feeding.
• Known allergy to methacrylates or other components of resin composites, local anesthetics, or metals used for dental restorations.
• An employee of the sponsor or members of their immediate family.
• Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome, xerogenic medications).
• Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues.
• Unable to return to the recall visits.
• Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.
• Teeth with implant restorations.

Sponsors & Collaborators

• Kerr Corporation: lead

Study Sites (1)

Nova Southeastern University, College of dental Medicine

Fort Lauderdale, Florida, 33328, United States

Location

Related Publications (3)

• Hill EE. Dental cements for definitive luting: a review and practical clinical considerations. Dent Clin North Am. 2007 Jul;51(3):643-58, vi. doi: 10.1016/j.cden.2007.04.002.

  PMID: 17586148 BACKGROUND

• Alharbi A, Rocca GT, Dietschi D, Krejci I. Semidirect composite onlay with cavity sealing: a review of clinical procedures. J Esthet Restor Dent. 2014 Mar-Apr;26(2):97-106. doi: 10.1111/jerd.12067. Epub 2013 Dec 17.

  PMID: 24341472 BACKGROUND

• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

  PMID: 20628774 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sibel Antonson

  NSU CDM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Assistant Dean for Research and Development

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 21, 2023
• Study Start: July 14, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)