Efficacy of Proximal Caries Infiltration

Caries Clinical Trial

Official title:

Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726179
• Other study ID #: ECIPRJ13
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2018

Study information

• Verified date: April 2022
• Source: DMG Dental Material Gesellschaft mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Dental Health

Intervention

Device:
• Resin infiltration
Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.
• Control
Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.

Locations

Country	Name	City	State
Brazil	Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
DMG Dental Material Gesellschaft mbH	Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017- — View Citation

Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries progression rate	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.	1 year
Secondary	Stress reaction during treatment	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.	Immediate
Secondary	Caries risk	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.	Baseline, 6 months, 1 year, 2 years, 3 years
Secondary	Caries progression rate	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.	2 years, 3 years