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Atraumatic Restorative Treatment Sealants in First Permanent Molars

Primary Purpose

Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glass ionomer sealant
Non-sealant (toothbrushing)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental focused on measuring Dentition, Permanent, Glass Ionomer Cements

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 ].

Exclusion Criteria:

  • patients presenting any physical and/or medical health issues and having non-cooperative behavior.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Glass ionomer sealant

    Non-sealant (toothbrushing)

    Arm Description

    Two hand-mixed glass ionomer cements (GICs) available in the dental market were used, and they were mixed according to the manufacturer's instructions (powder/liquid ratio 1:1). The molars were cleaned with a toothbrush and wet cotton wool pellets. Isolation was performed with cotton wool rolls and the occlusal surface was conditioned with GIC liquid (20s), rinsed with wet cotton wool pellets and dried with dry cotton wool pellets. GIC was placed on the occlusal surface and pressed into the pits and fissures using the press-finger technique. The excess of material was removed and the occlusion checked and adjusted. Sealant was protected with a new layer of petroleum jelly and the children were instructed not to eat for at least one hour. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months.

    No sealant was performed. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months.

    Outcomes

    Primary Outcome Measures

    Changes in glass ionomer selants retention
    The sealants retention was evaluated clinically using the criteria: 0) fully present sealant; 1) partially present sealant and 2) absent sealant [Oba AA, Dülgergil T, Sönmez IŞ, Doǧan S (2009) Comparison of Caries Prevention With Glass Ionomer and Composite Resin Fissure Sealants. J Formos Med Assoc 108:844-848]. Scores 0 and 1 were considered "success," whereas score 2 was considered "failure."

    Secondary Outcome Measures

    Changes in caries status of first permanent molars
    The examiners evaluated the presence of caries according to ICDAS [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178] and caries activity according to Nyvad criteria [Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260]. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures.
    Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities
    The examiners evaluated the presence of caries according to ICDAS [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178] and caries activity according to Nyvad criteria [Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260]. The comparison between the 2 cities was performed in order to verify if demographic/ population characteristics could interfere in the treatments. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures.

    Full Information

    First Posted
    August 21, 2018
    Last Updated
    November 7, 2018
    Sponsor
    University of Sao Paulo
    Collaborators
    Academic Centre for Dentistry in Amsterdam, Universidade Federal de Pernambuco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03667768
    Brief Title
    Atraumatic Restorative Treatment Sealants in First Permanent Molars
    Official Title
    Atraumatic Restorative Treatment Sealants in First Permanent Molars: a Bi-center Split-mouth Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Academic Centre for Dentistry in Amsterdam, Universidade Federal de Pernambuco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Dental
    Keywords
    Dentition, Permanent, Glass Ionomer Cements

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Split-mouth design
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    437 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glass ionomer sealant
    Arm Type
    Experimental
    Arm Description
    Two hand-mixed glass ionomer cements (GICs) available in the dental market were used, and they were mixed according to the manufacturer's instructions (powder/liquid ratio 1:1). The molars were cleaned with a toothbrush and wet cotton wool pellets. Isolation was performed with cotton wool rolls and the occlusal surface was conditioned with GIC liquid (20s), rinsed with wet cotton wool pellets and dried with dry cotton wool pellets. GIC was placed on the occlusal surface and pressed into the pits and fissures using the press-finger technique. The excess of material was removed and the occlusion checked and adjusted. Sealant was protected with a new layer of petroleum jelly and the children were instructed not to eat for at least one hour. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months.
    Arm Title
    Non-sealant (toothbrushing)
    Arm Type
    Other
    Arm Description
    No sealant was performed. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months.
    Intervention Type
    Procedure
    Intervention Name(s)
    Glass ionomer sealant
    Intervention Type
    Behavioral
    Intervention Name(s)
    Non-sealant (toothbrushing)
    Primary Outcome Measure Information:
    Title
    Changes in glass ionomer selants retention
    Description
    The sealants retention was evaluated clinically using the criteria: 0) fully present sealant; 1) partially present sealant and 2) absent sealant [Oba AA, Dülgergil T, Sönmez IŞ, Doǧan S (2009) Comparison of Caries Prevention With Glass Ionomer and Composite Resin Fissure Sealants. J Formos Med Assoc 108:844-848]. Scores 0 and 1 were considered "success," whereas score 2 was considered "failure."
    Time Frame
    3, 6, 12, 18, 24 and 36 months
    Secondary Outcome Measure Information:
    Title
    Changes in caries status of first permanent molars
    Description
    The examiners evaluated the presence of caries according to ICDAS [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178] and caries activity according to Nyvad criteria [Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260]. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures.
    Time Frame
    3, 6, 12, 18, 24 and 36 months
    Title
    Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities
    Description
    The examiners evaluated the presence of caries according to ICDAS [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178] and caries activity according to Nyvad criteria [Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260]. The comparison between the 2 cities was performed in order to verify if demographic/ population characteristics could interfere in the treatments. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures.
    Time Frame
    3, 6, 12, 18, 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 ]. Exclusion Criteria: patients presenting any physical and/or medical health issues and having non-cooperative behavior.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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