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

University of Copenhagen

Status: Unknown

Conditions: Dental Caries

Treatments: Other: Fissure sealing

Study type: Interventional

Funder types: Other

Identifiers

NCT02561689

UCopenhagen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children and adolescents 5-14 years of age
• Children with 2, 4, 6 or 8 molars assessed to be in need of prophylactic or therapeutic sealing
• The radiographic penetration of the occlusal caries lesion must be limited halfway through the dentin

Exclusion criteria

• In case the occlusal surface is restored with communication between the restoration and the included lesion
• Subjects with chronic diseases that could affect their caries pattern
• Pain in teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 participants in 2 patient groups

Fissure sealant material 1

Experimental group

Description:

Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro

Treatment:

Other: Fissure sealing

Fissure sealant material 2

Experimental group

Description:

Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro

Treatment:

Other: Fissure sealing