Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition (SEAL-DK)

April 28, 2021 updated by: Azam Bakhshandeh, University of Copenhagen

SEAL-DK: Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition in Children and Adolescents. RCT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The first restoration is fatal for the prognosis of the tooth. Studies have shown that caries progression can be stopped with a tight sealing which may even lead to re-mineralization of lesions.

Aim: To investigate the possibility of treating manifest occlusal caries with non-invasive sealing instead of conventional resin restoration.

Study design: the study is carried out as a prospective, randomized clinical study (RCT). Primary, occlusal caries lesions in 521 patients, aged 6-17 years old were treated by non-invasive resin based sealing (n= 368) or resin based restoration (n=153). The dentists or patients were not free to choose the treatment type. Randomization between sealing and restoration (2:1) was made by computer for each practitioner at the University of Copenhagen and kept at the clinics in sealed envelopes. The treatments are examined clinically and radiographically after 1, 2, 3, 5, 7 and 10 years. The treatments are performed and controlled by 68 general practitioners from Public Dental Health Care Service in 9 Danish municipalities.

Sealing: The dentists use material 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.

Restoration: The dentists use preparation design and material 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.

The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of patient, dentist or treatment related factors for assessing of statistically significant correlations.

The influence of each factor on the quality, longevity and need for retreatment of occlusal sealants and restorations, will be assessed using non-parametric tests and Kaplan-Meier survival analyses for statistical treatment of data, supplemented with summarizing multivariate survival analyses such as the Cox regression model and discriminatory analyses.

Study Type

Interventional

Enrollment (Actual)

521

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Non-invasive resin based fissure sealing
Application of resin based fissure sealing after acid etching of carious occlusal surface
Procedure: Non-invasive resin based fissure sealing
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
Other Names:
  • Sealing
ACTIVE_COMPARATOR: Invasive resin based restoration
Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface
Procedure: Invasive resin based restoration
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
Other Names:
  • Restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of fissure sealants
Time Frame: 10 years

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
Time Frame: 10 years

Clinical scoring system:

1) Intact sealing without caries progression (success) 2: Loss of sealant with or without caries progression (failure)
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of resin based restoration
Time Frame: 10 years

Radiographical scoring system:

1) Unchanged depth of lesion (success) 2: Progression in depth of lesion (failure)
10 years
Longevity of resin based restoration
Time Frame: 10

Clinical scoring system:

1) Intact restoration without caries progression (success) 2: Defect restoration with or without caries progression (failure)
10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Public Dental Health Care System, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (ESTIMATE)

October 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCopenhagen1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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