Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal

Study Overview
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Brief Summary
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This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This study will evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtek™ Universal Restorative as the filling material.

Detailed Description
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This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study. The study is designed to compare the clinical efficacy of Scotchbond™ Universal Plus Adhesive with Scotchbond™ Universal Adhesive when used in self-etch mode for preparation of posterior Class I and Class II restorations using Filtek™ Universal Restorative material in adult patients. Selected endpoints are based partly on the FDI World Dental Federation criteria. Subjects who meet all inclusion and none of the exclusion criteria and who have provided informed consent will be eligible for enrollment and must be treated within 21 days of screening. Either two pre-molars or two molars from each Subject will be randomized in a 1:1 ratio such that one of the teeth will be randomized to undergo restoration using SBU+ Adhesive (Treatment), and the other tooth will undergo restoration using SBU Adhesive (Control). Both study teeth will be restored using Filtek™ Universal Restorative material as the filling material. Individual subject participation is expected to last 2 years (± 45 days) with scheduled study visits at screening, day of restoration/baseline, and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restoration. Subjects may participate in additional unscheduled visits as required during the study if evaluation of any study tooth is required outside of the scheduled study visits. Unscheduled visits may be initiated by either the Investigator or the Subject. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days). To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, then the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit. A consensus will be reached before the Subject leaves the visit, and the consensus assessments will be entered into the Case Report Form (CRF).

Official Title
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Prospective, Randomized, Split-mouth Study Evaluating Clinical Performance of 3M™ Scotchbond™ Universal Plus Adhesive Compared to 3M Scotchbond Universal Adhesive for Posterior Class I & II Restorations With 3M Filtek™ Universal Restorative

Conditions
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Cavities of Teeth, Dental Decay

Intervention / Treatment
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* Device: Scotchbond™ Universal Plus Adhesive
* Device: Scotchbond™ Universal Adhesive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Subject is between the ages of 18 and 70 years old at time of consent. The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (< 1 mm in the buccolingual direction). Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established. The Subject is able and willing to sign Informed Consent Form in English without assistance. The Subject is able and willing to be available for all scheduled study visits. The Subject is in good general health (ie, meets ASA Level I or ASA Level II classification criteria). The selected teeth need to have occlusal contact with an antagonistic natural tooth. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months. Exclusion Criteria: The Subject has a history of adverse reaction to any materials used in this study. The Subject is pregnant or breast feeding at the time of screening. The Subject has fewer than 20 teeth. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study. The Subject has advanced periodontal disease (ie, Grace & Smales Mobility Index grade ≥ 2) that involve the study teeth. The Subject had orthodontic appliance treatment within the previous 3 months. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism. The Subject has severe xerostomia. The study tooth has a history of or existing, prolonged tooth hypersensitivity. The study tooth is an abutment for fixed or removable prostheses. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system. The Subject is unable to understand study procedures or provide consent in English. The Subject is an employee or student of the study investigator(s). Intraoperative Exclusion Criteria: 1) The Subject has pulp exposure of either study tooth during the restoration procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scotchbond Universal Plus Treatment<br>Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). | Device: Scotchbond™ Universal Plus Adhesive<br>* Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative<br>|
| Active Comparator: Scotchbond Universal Comparator<br>Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). | Device: Scotchbond™ Universal Adhesive<br>* Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of Restorative Material | The proportion of Subjects with partial or complete loss of the restoration materials | 24 months post-restoration | 
| Fracture of Restorative Material | Fractures on study teeth graded on a scale of 1-4 | 24 months post-restoration | 
| Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 | 24 months post-restoration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of Restorative Material | The proportion of Subjects with partial or complete loss of the restoration materials | 6 months and 12 months post-restoration | 
| Time to Restoration Failure | Restoration retention survival time defined as the time between restoration and the first report of partial or complete loss of restoration. | baseline to 24 months post-restoration | 
| Fracture of Restorative Material | Fractures on study teeth graded on a scale of 1-4 | 6 months and 12 months post-restoration | 
| Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 | baseline, 6 months, and 12 months post-restoration | 
| Approximal Anatomical Form | Approximal anatomical form (contact point) graded on a scale of 1-5 | baseline, 6 months, 12 months, and 24 months post-restoration | 
| Recurrent Caries | Incidence of recurrent caries graded on a scale of 1-5 | 6 months, 12 months, and 24 months | 
| Marginal staining | Marginal staining graded on a scale of 1-5 | baseline, 6 months, 12 months, and 24 months post-restoration | 
| Surface staining | Surface staining graded on a scale of 1-5 | baseline, 6 months, 12 months, and 24 months post-restoration | 
| Color match | Color match and translucency graded on a scale of 1-5 | baseline, 6 months, 12 months, and 24 months post-restoration | 
| Surface Luster | Surface luster, polish retention, surface gloss, roughness graded on a scale of 1-5 | baseline, 6 months, 12 months, and 24 months post-restoration | 
| Postoperative hypersensitivity | Postoperative hypersensitivity and tooth vitality graded on a scale of 1-5 | 6 months, 12 months, and 24 months post-restoration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental materials, dental adhesives, dental fillings, dental cavities, Scotchbond Universal Plus, Scotchbond Universal, Filtek Universal Restorative