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

NCT02561689 | Unknown DMC

• 1 other identifier: UCopenhagen
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Occlusal caries; Resin fissure sealant; Longevity; Effectiveness

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Fissure sealant material 1

EXPERIMENTAL

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

Fissure sealant material 2

EXPERIMENTAL

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

Interventions

Fissure sealing 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 1; Fissure sealant material 2

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Dental Health Care in Denmark

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Azam AB Bakhshandeh, PhD

  University of Copenhagen

  STUDY CHAIR

• Vibeke VQ Qvist, Dr Odont

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: September 28, 2015
• Study Start: January 1, 2014
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

DK (1)