In Vivo Assessment of the Tooth-Resin Composite Interface Using Optical Coherence Tomography

NCT05145322 | Completed Results FDA Device

• 1 other identifier: STUDY00011286
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.

Conditions

Cavity; Cavities of Teeth

Keywords

Dental Composite

Outcome Measures

Primary Outcomes (12)

• Marginal Staining: World Dental Federation (FDI) Criteria - Baseline

  The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at baseline.

  Baseline

• Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up

  The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 6 months post-operative.

  6 months Follow-up

• Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up

  The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 18 months post-operative.

  18 months Follow-up

• Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline

  The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline.

  Baseline

• Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up

  The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative.

  6 months Follow-up

• Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up

  The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative.

  18 months Follow-up

• Marginal Defect: World Dental Federation (FDI) Criteria - Baseline

  The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.

  Baseline

• Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up

  The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.

  6 months Follow-up

• Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative

  The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.

  18 months post-operative

• Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline

  The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline.

  Baseline

• Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up

  The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative.

  6 months Follow-up

• Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative

  The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative.

  18 months post-operative

Secondary Outcomes (3)

• Backscattered Intensity at the Occlusal Cavosurface Angle.

  Baseline

• Tooth-resin Interface Gap at the Occlusal Cavosurface Angle.

  Baseline

• Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls

  Baseline

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins

Device: Composite with 90 degree cavosurface angle

Group 2

EXPERIMENTAL

Lesion-specific cavity design with wide bevel throughout the cavity margins

Device: Composite with wide bevel

Interventions

Composite with 90 degree cavosurface angle DEVICE

Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.

Group 1

Composite with wide bevel DEVICE

Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good general health
• Fair oral hygiene
• At least 20 teeth in occlusion
• Available for the duration of the study
• Participants with occlusal caries lesion/s in permanent posterior dentition except wisdom teeth
• Caries lesion can be primary or secondary caries.
• Caries lesion is in the International Caries Detection and Assessment System (ICDAS) 4 or 5 category.
• The extent of the caries lesion bucco-lingually is likely not to exceed two-thirds of the occlusal table.
• The selected tooth must be able to be isolated with either rubber dam or other isolation technique during clinical procedure.
• The selected tooth must have an opposing antagonist.
• The selected tooth should be periodontally healthy.

You may not qualify if:

• \- Signs of bruxism
• Wisdom teeth
• Present with irreversible pulpitis.
• Periodontally compromised tooth that may require extraction.
• Caries lesions that would require cuspal coverage.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

• 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

• Ryge G, Snyder M. Evaluating the clinical quality of restorations. J Am Dent Assoc. 1973 Aug;87(2):369-77. doi: 10.14219/jada.archive.1973.0421. No abstract available.

  PMID: 4515696 BACKGROUND

• Nazari A, Sadr A, Shimada Y, Tagami J, Sumi Y. 3D assessment of void and gap formation in flowable resin composites using optical coherence tomography. J Adhes Dent. 2013 Jun;15(3):237-43. doi: 10.3290/j.jad.a28623.

  PMID: 23534012 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Hooi Pin Chew
• Organization: University of Minnesota School of Dentistry

chew0014@umn.edu

6126256975

Study Officials

• Hooi Pin Chew, BDS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: December 6, 2021
• Study Start: September 23, 2021
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Locations

US (1)