Lesion Progression After Icon Treatment in Young Adults

NCT01988337 | Terminated Results

• 1 other identifier: TOPIC36
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries; Salivary Function; Tooth Sensitivity

Keywords

Icon

Outcome Measures

Primary Outcomes (1)

• Number of Invasive Interventions (Fillings)

  Cumulative number of study lesions that have progressed to a state were an invasive intervention (filling) has been required to restore the teeth as determined via an dental examination (baseline versus 3 year follow up).

  3 years

Secondary Outcomes (1)

• Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)

  6 months and 12 months

Other Outcomes (1)

• Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response

  6 months and 12 months

Study Arms (2)

Resin infiltration

EXPERIMENTAL

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

Device: Resin infiltration

Mock treatment

SHAM COMPARATOR

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

Other: Mock treatment

Interventions

Resin infiltration 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.

Also known as: Icon (DMG, Germany), approximal resin infiltration kit

Resin infiltration

Mock treatment 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.

Mock treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Manager Clinical Research
• Organization: DMG Dental Material Gesellschaft mbH

clinicalresearch@mtcompanies.com

04084006

Study Officials

• Nate O. Lawson

  Birmingham, Alabama 35294; US

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-mouth design

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 20, 2013
• Study Start: August 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-09

Locations

US (1)