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

Dental Caries Clinical Trial

— SEALANT-DK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02561689
• Other study ID #: UCopenhagen
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Locations

Country	Name	City	State
Denmark	Dental Health Care in Denmark	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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