NCT02573090

Brief Summary

The research project "SEAL-DK" is focusing on advantages and disadvantages of two treatment strategies: non-invasive fissure sealing and invasive restorative treatment of manifest occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the project is to promote the understanding of the possibilities of non-invasive treatment of occlusal caries lesions in the permanent dentition, and to increase the present knowledge about the optimal threshold for sealing or restoration, respectively, when treating such lesions. The project is carried out as a randomized study of the two treatment strategies: non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is emphasized that no treatment shall be carried out, if conflicting the participating dentists' perception of clinically proper caries treatment, and that the results shall have a high reliability and consistency. The hypothesis is that caries progression can be stopped by non-invasive fissure sealing changing the threshold and postponing the time for invasive restoration.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

13.9 years

First QC Date

October 8, 2015

Last Update Submit

April 28, 2021

Conditions

Dental Caries

Keywords

Occlusal cariesResin based fissure sealantComposite resin restorationEffectivenessLongevity

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of fissure sealants

    Radiographical scoring system: 1\) Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)

    10 years

  • Longevity of fissure sealants

    Clinical scoring system: 1\) Intact sealing without caries progression (success) 2: Loss of sealant with or without caries progression (failure)

    10 years

Secondary Outcomes (2)

  • Effectiveness of resin based restoration

    10 years

  • Longevity of resin based restoration

    10

Study Arms (2)

Non-invasive resin based fissure sealing

EXPERIMENTAL

Application of resin based fissure sealing after acid etching of carious occlusal surface

Procedure: Non-invasive resin based fissure sealing

Invasive resin based restoration

ACTIVE COMPARATOR

Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface

Procedure: Invasive resin based restoration

Interventions

Non-invasive resin based fissure sealingPROCEDURE

The dentists use resin based fissure sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK

Also known as: Sealing
Non-invasive resin based fissure sealing
Invasive resin based restorationPROCEDURE

The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK

Also known as: Restoration
Invasive resin based restoration

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • each patient should have one manifest occlusal caries lesion in need of restorative treatment
  • the radiographic depth of the lesion should be limited to half through the dentin
  • written informed consent from children and parents should be obtained before treatment

You may not qualify if:

  • when the occlusal lesion had communication with an approximal caries lesion or occlusal/approximal restoration
  • the tooth was hypomineralized
  • in case of serious chronic diseases affecting the caries experience and activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Interventions

calcium sulfate, zinc oxide, vinyl acetate, zinc phosphate root canal filling

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 9, 2015

Study Start

November 1, 2006

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

May 3, 2021

Record last verified: 2021-04