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Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

NCT ID: NCT03819868

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2019-12-31

Brief Summary

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The sealing of fossae and fissures is an effective procedure in preventing occlusal caries lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel lesions. In addition, there are no studies in the literature that have compared the longevity of sealings performed with the different sealants available in the market. Thus, the objective of this study is to evaluate the efficacy of fossae and fissures sealings performed with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous molars. This is a multicenter clinical study of non-inferiority, randomized, controlled, double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized into two groups using a distributed randomization list in mixed envelopes that will be open only at the time of the procedure. The teeth allocated in the test group will be treated with the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and 18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and quality of life, will also be evaluated.

Detailed Description

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Conditions

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Dental Caries

Keywords

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dental caries molars Pit and Fissure Sealants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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High Cost

Restoration using a high-cost sealant

Group Type ACTIVE_COMPARATOR

High cost

Intervention Type PROCEDURE

Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.

Low Cost

Restoration using a low-cost sealant

Group Type EXPERIMENTAL

Low Cost

Intervention Type PROCEDURE

Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.

Interventions

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High cost

Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.

Intervention Type PROCEDURE

Low Cost

Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children with at least two deciduous and/or permanent molars with occlusal caries lesions scores 1, 2 or 3 of the Icdas (Ismail et al., 2007) will be included, one on each side, preferably from the same arch.

Exclusion Criteria

* Patients with special needs;
* using orthodontic appliances;
* with systemic diseases;
* Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp impairment;
* teeth with fistula and/or abscess;
* teeth with spontaneous painful symptomatology.
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty Sao Leopoldo Mandic Campinas

OTHER

Sponsor Role lead

Responsible Party

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Jose Carlos P Imparato

PhD, Senior Lecturer, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty Sao Leopoldo Mandic

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jose Carlos P Imparato, PhD

Role: CONTACT

Phone: +5511998686008

Email: [email protected]

Facility Contacts

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Jose Carlos P Imparato, PhD

Role: primary

References

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Hesse D, Bonifacio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health. 2014 May 28;14:58. doi: 10.1186/1472-6831-14-58.

Reference Type RESULT
PMID: 24884684 (View on PubMed)

Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.

Reference Type RESULT
PMID: 19761288 (View on PubMed)

Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.

Reference Type RESULT
PMID: 18709230 (View on PubMed)

Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

Reference Type RESULT
PMID: 3344163 (View on PubMed)

Pitts N, Melo P, Martignon S, Ekstrand K, Ismail A. Caries risk assessment, diagnosis and synthesis in the context of a European Core Curriculum in Cariology. Eur J Dent Educ. 2011 Nov;15 Suppl 1:23-31. doi: 10.1111/j.1600-0579.2011.00711.x.

Reference Type RESULT
PMID: 22023543 (View on PubMed)

Other Identifiers

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SLM 5

Identifier Type: -

Identifier Source: org_study_id