SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents (SEALANT-DK)
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fissure sealing
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Occlusal caries, Resin fissure sealant, Longevity, Effectiveness
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
Sites / Locations
- Dental Health Care in Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fissure sealant material 1
Fissure sealant material 2
Arm Description
Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro
Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02561689
First Posted
December 2, 2014
Last Updated
September 27, 2021
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02561689
Brief Title
SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents
Acronym
SEALANT-DK
Official Title
SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Occlusal caries, Resin fissure sealant, Longevity, Effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fissure sealant material 1
Arm Type
Experimental
Arm Description
Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro
Arm Title
Fissure sealant material 2
Arm Type
Experimental
Arm Description
Fissure sealing with Delton FS+ Fissure sealing withClinpro Sealant Fissure sealing withGrandio Seal Fissure sealing withControl Seal Fissure sealing withUltraSeal XT+ UltraSeal XT hydro
Intervention Type
Other
Intervention Name(s)
Fissure sealing
Intervention Description
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
Primary Outcome Measure Information:
Title
Longevity of 6 resin fissure sealants assessed by defined scoring system
Description
Clinical scoring system: 1: Intact sealing (success), 2: Partly loss of sealant (failure); 3: Total loss of sealant (failure)
Time Frame
5 years
Title
Efficacy of 6 resin fissure sealants assessed by defined radiological scoring system
Description
Radiographic scoring system: 1:Regression in depth of lesion (success), 2: Unchanged depth of lesion (success); 3: Progression in depth of lesion (failure)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azam AB Bakhshandeh, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vibeke VQ Qvist, Dr Odont
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Dental Health Care in Denmark
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents
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