Lesion Progression After Icon Treatment in Young Adults

Not Applicable

Terminated

Conditions: Salivary Function
Tooth Sensitivity
Caries

Interventions: Other: Mock treatment
Device: Resin infiltration

Registration Number: NCT01988337

Lead Sponsor: DMG Dental Material Gesellschaft mbH

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Invasive Interventions (Fillings)	3 years	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).

Secondary Outcome Measures

Name	Time	Method
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)	6 months and 12 months	Change in categorical lesion depth (progression to next depth category lesion; E1-\>E2-\>D1-\>D2-\>filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin). Reference: Anusavice K. Present and future approaches for the control of caries. J Dent Educ. 2005;69(5):538-854.