search
Back to results

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

Primary Purpose

Cavities of Teeth, Dental Decay

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scotchbond™ Universal Plus Adhesive
Scotchbond™ Universal Adhesive
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cavities of Teeth focused on measuring dental materials, dental adhesives, dental fillings, dental cavities, Scotchbond Universal Plus, Scotchbond Universal, Filtek Universal Restorative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The Subject is between the ages of 18 and 70 years old at time of consent.
  2. 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).
  3. 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
  4. 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.
  5. The Subject is able and willing to sign Informed Consent Form in English without assistance.
  6. The Subject is able and willing to be available for all scheduled study visits.
  7. The Subject is in good general health (ie, meets ASA Level I or ASA Level II classification criteria).
  8. The selected teeth need to have occlusal contact with an antagonistic natural tooth.
  9. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.

Exclusion Criteria:

  1. The Subject has a history of adverse reaction to any materials used in this study.
  2. The Subject is pregnant or breast feeding at the time of screening.
  3. The Subject has fewer than 20 teeth.
  4. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study.
  5. The Subject has advanced periodontal disease (ie, Grace & Smales Mobility Index grade ≥ 2) that involve the study teeth.
  6. The Subject had orthodontic appliance treatment within the previous 3 months.
  7. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism.
  8. The Subject has severe xerostomia.
  9. The study tooth has a history of or existing, prolonged tooth hypersensitivity.
  10. The study tooth is an abutment for fixed or removable prostheses.
  11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth.
  12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system.
  13. The Subject is unable to understand study procedures or provide consent in English.
  14. 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.

Sites / Locations

  • University of Minnesota School of Dentristry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scotchbond Universal Plus Treatment

Scotchbond Universal Comparator

Arm Description

Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).

Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).

Outcomes

Primary Outcome Measures

Retention of Restorative Material
The proportion of Subjects with partial or complete loss of the restoration materials
Fracture of Restorative Material
Fractures on study teeth graded on a scale of 1-4
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5

Secondary Outcome Measures

Retention of Restorative Material
The proportion of Subjects with partial or complete loss of the restoration materials
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.
Fracture of Restorative Material
Fractures on study teeth graded on a scale of 1-4
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5
Approximal Anatomical Form
Approximal anatomical form (contact point) graded on a scale of 1-5
Recurrent Caries
Incidence of recurrent caries graded on a scale of 1-5
Marginal staining
Marginal staining graded on a scale of 1-5
Surface staining
Surface staining graded on a scale of 1-5
Color match
Color match and translucency graded on a scale of 1-5
Surface Luster
Surface luster, polish retention, surface gloss, roughness graded on a scale of 1-5
Postoperative hypersensitivity
Postoperative hypersensitivity and tooth vitality graded on a scale of 1-5

Full Information

First Posted
February 10, 2022
Last Updated
October 10, 2023
Sponsor
3M
search

1. Study Identification

Unique Protocol Identification Number
NCT05248204
Brief Title
Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cavities of Teeth, Dental Decay
Keywords
dental materials, dental adhesives, dental fillings, dental cavities, Scotchbond Universal Plus, Scotchbond Universal, Filtek Universal Restorative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scotchbond Universal Plus Treatment
Arm Type
Experimental
Arm Description
Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).
Arm Title
Scotchbond Universal Comparator
Arm Type
Active Comparator
Arm Description
Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).
Intervention Type
Device
Intervention Name(s)
Scotchbond™ Universal Plus Adhesive
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Scotchbond™ Universal Adhesive
Intervention Description
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
Primary Outcome Measure Information:
Title
Retention of Restorative Material
Description
The proportion of Subjects with partial or complete loss of the restoration materials
Time Frame
24 months post-restoration
Title
Fracture of Restorative Material
Description
Fractures on study teeth graded on a scale of 1-4
Time Frame
24 months post-restoration
Title
Marginal Adaptation
Description
Marginal adaptation of restorations graded on a scale of 1-5
Time Frame
24 months post-restoration
Secondary Outcome Measure Information:
Title
Retention of Restorative Material
Description
The proportion of Subjects with partial or complete loss of the restoration materials
Time Frame
6 months and 12 months post-restoration
Title
Time to Restoration Failure
Description
Restoration retention survival time defined as the time between restoration and the first report of partial or complete loss of restoration.
Time Frame
baseline to 24 months post-restoration
Title
Fracture of Restorative Material
Description
Fractures on study teeth graded on a scale of 1-4
Time Frame
6 months and 12 months post-restoration
Title
Marginal Adaptation
Description
Marginal adaptation of restorations graded on a scale of 1-5
Time Frame
baseline, 6 months, and 12 months post-restoration
Title
Approximal Anatomical Form
Description
Approximal anatomical form (contact point) graded on a scale of 1-5
Time Frame
baseline, 6 months, 12 months, and 24 months post-restoration
Title
Recurrent Caries
Description
Incidence of recurrent caries graded on a scale of 1-5
Time Frame
6 months, 12 months, and 24 months
Title
Marginal staining
Description
Marginal staining graded on a scale of 1-5
Time Frame
baseline, 6 months, 12 months, and 24 months post-restoration
Title
Surface staining
Description
Surface staining graded on a scale of 1-5
Time Frame
baseline, 6 months, 12 months, and 24 months post-restoration
Title
Color match
Description
Color match and translucency graded on a scale of 1-5
Time Frame
baseline, 6 months, 12 months, and 24 months post-restoration
Title
Surface Luster
Description
Surface luster, polish retention, surface gloss, roughness graded on a scale of 1-5
Time Frame
baseline, 6 months, 12 months, and 24 months post-restoration
Title
Postoperative hypersensitivity
Description
Postoperative hypersensitivity and tooth vitality graded on a scale of 1-5
Time Frame
6 months, 12 months, and 24 months post-restoration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Perdigao, DMD, MS, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota School of Dentristry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20628774
Citation
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.
Results Reference
background
PubMed Identifier
19492717
Citation
Perdigao J, Dutra-Correa M, Anauate-Netto C, Castilhos N, Carmo AR, Lewgoy HR, Amore R, Cordeiro HJ. Two-year clinical evaluation of self-etching adhesives in posterior restorations. J Adhes Dent. 2009 Apr;11(2):149-59.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs