Clinical trial NCT01988337: Lesion Progression After Icon Treatment in Young Adults
Official title: Double Blind Randomized Controlled Clinical Trial of Lesion Progression After Treatment With Icon vs. Placebo in Caries Lesions in Young Adults Over 36 Months
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Caries
Salivary Function
Tooth Sensitivity
Keywords: Icon
Lead sponsor: DMG Dental Material Gesellschaft mbH
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design
Primary purpose: PREVENTION

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.

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

Exclusion Criteria:

* Do not meet the inclusion criteria
* 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

Primary outcomes:
measure: Number of Invasive Interventions (Fillings)
timeFrame: 3 years
Secondary outcomes:
measure: Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
timeFrame: 6 months and 12 months
Other outcomes:
measure: Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response
timeFrame: 6 months and 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: Birmingham, Alabama 35294; US
name: Nate O. Lawson
role: PRINCIPAL_INVESTIGATOR
References: