- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667768
Atraumatic Restorative Treatment Sealants in First Permanent Molars
Atraumatic Restorative Treatment Sealants in First Permanent Molars: a Bi-center Split-mouth Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glass ionomer sealant
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.
|
|
Other: Non-sealant (toothbrushing)
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in glass ionomer selants retention
Time Frame: 3, 6, 12, 18, 24 and 36 months
|
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."
|
3, 6, 12, 18, 24 and 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in caries status of first permanent molars
Time Frame: 3, 6, 12, 18, 24 and 36 months
|
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. |
3, 6, 12, 18, 24 and 36 months
|
Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities
Time Frame: 3, 6, 12, 18, 24 months
|
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.
|
3, 6, 12, 18, 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USP-SaoPaulo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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