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

NCT ID: NCT02561689

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Fissure sealing

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Fissure sealing

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Azam Bakhshandeh

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azam AB Bakhshandeh, PhD

Role: STUDY_CHAIR

University of Copenhagen

Vibeke VQ Qvist, Dr Odont

Role: STUDY_CHAIR

University of Copenhagen

Locations

Dental Health Care in Denmark

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

UCopenhagen

Identifier Type: -

Identifier Source: org_study_id