NCT02561689

SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Background: Occlusal caries is the main reason for restorative therapy in the young permanent dentition, but restorations have limited survival time and may also weaken the tooth. An intact fissure sealing is an effective preventive treatment of occlusal caries lesions and may be used therapeutically to arrest the caries progression. However, the major challenge with fissure sealants is the frequent need for re-treatments, mostly due to inadequate retention. Purpose: To quantify the longevity and effectiveness of the 6 resin sealants used prophylactically and therapeutically in permanent molar teeth. Study design: The study is carried out as a prospective, clinically controlled study with split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities in Denmark uses 2 of the 6 sealants. The treatments are examined clinically and radiologically after 1, 2, 3, and 5 years.

Detailed description

The choice of the two materials is randomized and carried out so that all materials are used equally frequent and with an even distribution between dentists and dental hygienists.

Conditions

• Dental Caries

Interventions

Type	Name	Description
OTHER	Fissure sealing	Procedure: * The included teeth of the participating patients will in any case be sealed, but in this study, the operator is not free to choose the material, the material choice is determined by randomisation * Standardized radiographs (bitewings) will be taken before treatment and after 1, 2, 3 years and possibly after 5 years. Baseline radiograph can be taken up to six months before treatment. If using conventional radiography, double-film packs will be used. A maximum of 8/10 bitewings will be taken during the study period of 3/5 years * The occlusal surface is sealed by the dentist or dental hygienist. * Clinical evaluation of the quality of sealants and the need for re-treatments during the follow-up will be performed after 1, 2 and 3 years and possibly after 5 years

Timeline

• Start date: 2014-01-01
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2015-09-28
• Last updated: 2021-09-28

Locations

1 site across 1 country: Denmark