What is the mechanism of action of this treatment?

Common treatments for cavities include chemomechanical caries removal and conventional rotary or hand excavation. Chemomechanical caries removal uses a chemical agent to soften decayed dentin, which is then removed with hand instruments, aiming to preserve more healthy tooth structure and reduce discomfort. Conventional rotary excavation employs high-speed drills for quick removal of decay but can be more invasive. Hand excavation is less invasive but more time-consuming. These methods matter for cavity patients as they affect the preservation of healthy tooth structure, treatment comfort, and overall dental health outcomes.

What side effects are associated with this type of intervention?

Common treatments for cavities, particularly those involving Class I composite restorations, include the removal of decayed tooth material and the application of composite resin. Known side effects of these treatments can include postoperative sensitivity, which may result from the removal of tooth structure or the bonding process. Other potential side effects include marginal discoloration, secondary caries, and wear or fracture of the composite material over time. Additionally, improper technique during preparation or application can lead to poor marginal integrity, which may compromise the longevity of the restoration.

What prior FDA approvals exist?

The FDA has approved various materials and techniques for the treatment of cavities, particularly those involving composite restorations. Composite resins, such as those used in Class I composite restorations, are commonly approved materials. These resins are tooth-colored and used to fill cavities after the decayed portion of the tooth is removed. The preparation techniques for these restorations, which may involve etching, bonding, and layering of the composite material, are critical for ensuring the longevity and effectiveness of the treatment. Specific products and materials, such as those containing bis-GMA (bisphenol A-glycidyl methacrylate) and other resin-based composites, have received FDA approval for dental use.

What other types of research exist?

Promising novel alternatives to traditional preparation techniques for Class I composite restorations include the use of Optical Coherence Tomography (OCT) for precise assessment of marginal integrity, and the development of advanced composite materials that offer better adhesion and durability. These innovations aim to enhance the accuracy and longevity of restorations, providing better outcomes for patients.

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Composite Resin

Tooth Preparation Techniques for Cavities

N/A

Waitlist Available

Led By Hooi Pin Chew, BDS, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The selected tooth must have an opposing antagonist

The selected tooth must be able to be isolated with either rubber dam or other isolation technique during clinical procedure

Must not have

Present with irreversible pulpitis

Signs of bruxism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two methods for filling cavities in back teeth. It focuses on patients who need these specific types of fillings. The study uses visual checks and a special imaging technique to see how well the fillings work.

Who is the study for?

This trial is for individuals with irreversible pulpitis, good oral hygiene, and available for the study duration. They must have occlusal caries in permanent teeth (except wisdom teeth) that are periodontally healthy and not require cuspal coverage. Participants need at least 20 teeth in occlusion and be able to isolate the tooth during procedures.

What is being tested?

The study compares two techniques of preparing cavities for composite fillings: one with a wide bevel and another with a 90-degree angle. It uses visual assessments and Optical Coherence Tomography (OCT) to check how well the filling bonds to the tooth over time.

What are the potential side effects?

While this trial does not involve drugs, there may be general risks associated with dental procedures such as discomfort, sensitivity in the treated area, or potential damage to adjacent teeth during preparation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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The tooth being treated has a matching tooth it bites against.

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My tooth can be isolated for treatment using a special technique.

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My selected tooth is healthy and not affected by gum disease.

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I have at least 20 teeth that touch when I bite down.

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I have cavities in my back teeth, but not including wisdom teeth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a permanent nerve damage in my tooth.

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I grind my teeth.

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I need dental work that covers the tops of my teeth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+9 more

Secondary study objectives

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

Backscattered Intensity at the Occlusal Cavosurface Angle.

Tooth-resin Interface Gap at the Occlusal Cavosurface Angle.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

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

Group II: Group 1Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Composite with wide bevel

2021

N/A

~40

Composite with 90 degree cavosurface angle

2021

N/A

~40

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cavities include chemomechanical caries removal and conventional rotary or hand excavation. Chemomechanical caries removal uses a chemical agent to soften decayed dentin, which is then removed with hand instruments, aiming to preserve more healthy tooth structure and reduce discomfort. Conventional rotary excavation employs high-speed drills for quick removal of decay but can be more invasive. Hand excavation is less invasive but more time-consuming. These methods matter for cavity patients as they affect the preservation of healthy tooth structure, treatment comfort, and overall dental health outcomes.

Management of deep caries and the exposed pulp.Systematic Review and Meta-Analysis of Randomized Clinical Trials on Chemomechanical Caries Removal.Chemomechanical Excavation is More Time-consuming Than Rotary, but not Necessarily Hand Excavation.