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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

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:

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.

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

NCT ID

NCT05248204

First Posted

February 10, 2022

Last Updated

October 10, 2023

Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

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