Efficacy of Proximal Caries Infiltration

Not Applicable

Completed

• Conditions: Dental Health; Caries
• Interventions: Device: Resin infiltration; Device: Control

• Registration Number: NCT01726179
• Lead Sponsor: DMG Dental Material Gesellschaft mbH

Brief Summary

The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.

Detailed Description

The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

Study Timeline

• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Study Start: 2013-12
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• children with one tooth surface with active caries lesions
• two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
• asigned informed consent.

Exclusion Criteria

• children who do not cooperate during dental appointments
• primary molars supposed to exfoliate in less than two years
• lesions showing obvious cavitation or clear sings of inactivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin infiltration	Resin infiltration	This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day. Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
Control	Control	This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day. Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.

Primary Outcome Measures

Name	Time	Method
Caries progression rate	1 year	Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.

Secondary Outcome Measures

Name	Time	Method
Caries progression rate	2 years, 3 years	Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression in long term. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
Stress reaction during treatment	Immediate	To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.; A facial image scale with five faces ranging from very happy (1) to very unhappy (5) will be used.
Caries risk	Baseline, 6 months, 1 year, 2 years, 3 years	Caries risk is asses based on caries index (Nyvad criteria), proximal plaque index (0 = no visible plaque; 1 = visible plaque) and gingival bleeding index (0 = no bleeding after flossing; 1 = bleeding after flossing), dietary habits, and exposition to fluorides based on the Cariogram model.

Trial Locations

Locations (1)

Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.; 🇧🇷 Rio de Janeiro, Brazil