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

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: Fissure sealing

• Registration Number: NCT02561689
• Lead Sponsor: University of Copenhagen

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fissure sealant material 2	Fissure sealing	Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro
Fissure sealant material 1	Fissure sealing	Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro

Primary Outcome Measures

Name	Time	Method
Efficacy of 6 resin fissure sealants assessed by defined radiological scoring system	5 years	Radiographic scoring system: 1:Regression in depth of lesion (success), 2: Unchanged depth of lesion (success); 3: Progression in depth of lesion (failure)
Longevity of 6 resin fissure sealants assessed by defined scoring system	5 years	Clinical scoring system: 1: Intact sealing (success), 2: Partly loss of sealant (failure); 3: Total loss of sealant (failure)

Trial Locations

Locations (1)

Dental Health Care in Denmark; 🇩🇰 Copenhagen, Denmark