The Effectiveness of Slow-Release Fluoride Resin Modified Glass Ionomer Cement in the Treatment of Initial Active Proximal Caries LesionsA Randomized Controlled Clinical Trial

Phase 2

• Conditions: K02.0; Caries limited to enamel

• Registration Number: DRKS00034145
• Lead Sponsor: niversität Greifswald, Zentrum für Zahn-, Mund- und Kieferheilkunde, Poliklinik für Kinderzahnheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1)Children with high risk of caries.
2)Cooperative children. Only Code 3 and 4 according to Frankl behavior rating scale
3)Children willing to actively participate and appear to follow-up
4)The existence of the written declaration of consent of the study participants or their legal guardians.
- Inclusion criteria for tooth selection
1)?Primary molar or permanent molar or premolar with initial proximal caries lesions ?extending radiographically to the enamel ?(E1, E2), or the outer one third of dentine, just passing the EDJ (D1). (Young et al., 2015)
2)Activity of the lesion: bleeding on probing in the proximal area of the lesion will be used as a criterion to assess the activity of the lesion.

Exclusion Criteria

1)Children with general diseases and allergies.
2)Patient with dry mouth.
3)Patients who have already bitewings no older than 9 months but older than 1 month
4)Children whose parents are not willing to participate in the study, and refuse to return back for follow-up visits and most importantly after 12 months for a second bitewing radiograph.

Study & Design

• Study Type: interventional
• Study Design: Not specified