Clinical trial NCT05361746: Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs
Official title: Clinical Performance of a New Dental Adhesive, 3M™ Scotchbond™ Universal Plus Adhesive, Compared to 3M™ Scotchbond™ Universal Adhesive When Used With 3M™ Filtek™ Universal Restorative to Restore Class V Non-carious Cervical Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class V Non-carious Cervical Dental Lesions
Keywords: composite resins
dental adhesives
noncarious lesions
abfraction lesions
bonding, dental
clinical study
Scotchbond Universal plus
Scotchbond Universal
Filtek
dental materials
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will have either two restorations (two teeth) or four restorations (four teeth) performed at the beginning of the study, with each tooth restoration using only one type of adhesive. Study teeth will be paired according to lesion depth and randomized to treatment in a 1:1 ratio with at least half of the teeth (ie, 1 tooth for Subjects with 2 eligible teeth or 2 teeth for Subjects with 4 eligible teeth) randomized to undergo restoration(s) using Scotchbond Universal Plus Adhesive (SBU+ Treatment group) and the other half of the teeth undergoing restoration(s) using Scotchbond Universal Adhesive (SBU Control group).
Primary purpose: TREATMENT

Brief summary: This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus and Scotchbond Universal adhesives when used with Filtek restorative. The study will enroll a minimum of 46 Subjects with Class-V non-carious cervical lesion (NCCL) on a minimum of two teeth.

Detailed description: This is a prospective, controlled, within-subject, randomized, single-center study that will enroll Subjects scheduled to undergo Class-V NCCL restorations on 2 or 4 teeth treated in pairs according to lesion depth. The study will enroll a minimum of 46 Subjects from a single site located in Birmingham, AL, USA. Each study tooth will be restored using only one type of adhesive, either SBU+ or SBU, and Filtek restorative. Any teeth needing treatment that are not included in the study will be treated by the dentist using the standard of care.

Subjects will be seen during screening (≤21 days before the restoration procedure), on the day of the restoration procedure, 7 days (± 3 days) after restoration (remote visit for subject self-assessment of baseline hypersensitivity), and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restorations. Study teeth will be assessed for selected endpoints based partly on FDI World Dental Federation criteria. 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. 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 2 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, the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit before the Subject leaves the visit. The consensus assessments will be entered into the Case Report Form (CRF).

Eligibility criteria: Inclusion Criteria:

Subjects may be included that meet the following criteria:

1. Subject is at least 18 years of age at the time of consent
2. Subject is able to provide their own informed consent
3. Subject has a minimum of two teeth that:

   * have non-carious Class V lesions that are at least 1.5 mm deep
   * are not devitalized
   * have not undergone root canal treatment
4. Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents
5. Subject is able and willing to return for all scheduled study visits
6. Subject meets the Level-I or Level-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care

Exclusion Criteria:

Subjects may not be included that meet any of the following criteria:

1. Subject has any of the following:

   * rampant caries
   * chronic periodontitis
   * salivary gland dysfunction
2. Subject is unable, for any reason, to tolerate the procedure time required to place the restorations
3. Subject has unacceptable oral hygiene (eg, chronic moderate to heavy plaque accumulation along the gumline)
4. Subject has known sensitivity to the study product components (ie, acrylate)
5. Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Primary outcomes:
measure: Restoration Retention
timeFrame: 24 months
measure: Marginal Adaptation
timeFrame: 24 months
Secondary outcomes:
measure: Restoration Retention
timeFrame: baseline, 6 months, 12 months
measure: Marginal Adaptation
timeFrame: baseline, 6 months, 12 months
measure: Fracture of Restorative Material
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Secondary Caries
timeFrame: baseline, 6 months, 12 months, 24 months
Other outcomes:
measure: Surface staining
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Marginal staining
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Color match
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Polish retention
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Post-operative hypersensitivity and tooth vitality
timeFrame: 6 months, 12 months, 24 months
measure: Time to restoration failure
timeFrame: 24 months
measure: Patient satisfaction
timeFrame: baseline, 6 months, 12 months, 24 months
measure: Incidence of adverse events
timeFrame: 24 months
measure: Baseline post-operative hypersensitivity (subject self-assessment)
timeFrame: 7 days
Locations:
city: New Orleans
country: United States
facility: Louisiana State University HSC-Health, School of Dentistry
state: Louisiana
Study officials:
affiliation: Louisiana State University HSC Health, School of Dentistry
name: John Burgess, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Burgess JO, Sadid-Zadeh R, Cakir D, Ramp LC. Clinical evaluation of self-etch and total-etch adhesive systems in noncarious cervical lesions: a two-year report. Oper Dent. 2013 Sep-Oct;38(5):477-87. doi: 10.2341/12-355-CR. Epub 2013 Jan 17.
citation: Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.