Lesion Progression After Icon Treatment in Young Adults

NCT ID: NCT01988337

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-07-31

Brief Summary

This is a three year single site clinical evaluation of a FDA approved (510(k):K100062) lesion penetrating resin used to infiltrate and hamper progression of proximal carious lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon, Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The study is designed as a randomized, controlled, prospective clinical trial with a three year follow-up evaluation period.

The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2 study lesions. The patients will be evaluated at six time points over a period of 3 years. Lesion status and caries risk will be monitored at 6-month intervals, while radiographic evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.

Detailed Description

Introduction Dental caries is the most widespread of all diseases. It causes destruction of tooth structure by dissolving the enamel on the outside of the tooth first and then progressing into the inside of the tooth. While it is possible to use traditional dental fillings to replace diseased tooth structure, it is far better to slow down or reverse the disease process so that no fillings are needed. One of the most difficult places to use preventive or non-surgical treatment is the contact area between teeth. Recently there is evolving interest in using composites to infiltrate enamel and dentin areas that have just begun to be destroyed by caries. The infiltration technique arrests the lesion progression by sealing the porous surface and restores the damage avoiding ongoing acidic damage of tooth structure.

Objective Assess the clinical efficacy s of using Icon to infiltrate initial lesions below the tooth surfaces that exist on the contact surfaces between posterior teeth as a means of stabilizing diseased tooth structure and arresting further lesion development.

Materials and Methods One hundred fifty volunteers (19+ years) with two early lesions in posterior teeth will be enrolled into a clinical trial to evaluate the clinical efficacy of infiltrating the lesions as compared to current watch-and-wait approaches that are combined with good oral hygiene and fluoride application. Each subject will have a treated lesion and a control lesion. Only small early lesions without clinical signs of surface cavitation will be selected. The control lesions will be stabilized through a normal preventive regimen, while the treatment lesions will be infiltrated with a resin. Lesion status will be monitored every six months by clinical examination and as well using annual radiographs.

Clinical Significance Infiltrating a caries lesion is a potential effective strategy to strengthen damaged tooth structure and to reduce caries progression without any surgical intervention.

Conditions

Caries; Salivary Function; Tooth Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Resin infiltration

One proximal caries lesion (split mouth design) per patient will be treated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions.

Group Type: EXPERIMENTAL

Resin infiltration

Intervention Type: DEVICE

The study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactures´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first.

Mock treatment

A second proximal caries lesion of each patient (split mouth design) will receive a placebo treatment to mimic "resin infiltration".

Group Type: SHAM_COMPARATOR

Mock treatment

Intervention Type: OTHER

For the mock treatment the procedure will be identical to the "Resin Infiltration" intervention, with the exception that a placebo will be used. Essentially, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material.

Interventions

Resin infiltration

The study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactures´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first.

Intervention Type: DEVICE

Mock treatment

For the mock treatment the procedure will be identical to the "Resin Infiltration" intervention, with the exception that a placebo will be used. Essentially, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material.

Intervention Type: OTHER

Other Intervention Names

Icon (DMG, Germany), approximal resin infiltration kit

Eligibility Criteria

Inclusion Criteria

• Be age 19 years and older
• Have at least two vital carious teeth with caries ranging from enamel to just into dentin.

• If the lesion is not on a 3rd molar
• If the lesion is not developmental.
• If the lesion is not cavitated
• Be a regular dental attendee able to return for assessments
• Be in good medical health and able to tolerate the dental procedure
• Have no chronic periodontitis which could compromise tooth retention.
• Have normal salivary function.
• Have normal bone levels
• No lingering cold sensitivity
• No periapical sensitivity
• No sensitivity to percussion

• Are not able to tolerate the time required for the study
• There is a history of an adverse reaction to any materials used in the study
• They are irregular dental attendees
• They maintain an unacceptable standard of oral hygiene.
• They have chronic periodontitis
• There is severe salivary gland dysfunction or reduced salivary flow is observed
• They are unable to return for recall appointments

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DMG Dental Material Gesellschaft mbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nate O. Lawson

Role: PRINCIPAL_INVESTIGATOR

Birmingham, Alabama 35294; US

Locations

University of Alabama

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TOPIC36

Identifier Type: -

Identifier Source: org_study_id