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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Other: Fissure sealing

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 Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Dental Health Care in Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fissure sealant material 1; Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro	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
Experimental: Fissure sealant material 2; Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Study Chair: Azam AB Bakhshandeh, PhD, University of Copenhagen; Study Chair: Vibeke VQ Qvist, Dr Odont, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 28, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Effectiveness; Longevity; Occlusal caries; Resin fissure sealant
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: UCopenhagen