Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

August 15, 2017

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed

17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed

Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

January 22, 2019

Last Update Submit

December 9, 2019

Conditions

Dental Caries

Keywords

dental cariesmolarsPit and Fissure Sealants

Outcome Measures

Primary Outcomes (1)

Dental caries progression
Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as: * Present progression: Increased radiolucidity area of the Lesion * Absent progression: No increase in the area of radiolucidity of the lesion.
Every 6 months up to 18 months

Secondary Outcomes (4)

Cost-effectiveness
18 months
Impact on children's quality of life
Baseline and 18 months
Children self-reported discomfort
Baseline
Sealant retention
Every 6 months up to 18 months

Study Arms (2)

High Cost

ACTIVE COMPARATOR

Restoration using a high-cost sealant

Procedure: High cost

Low Cost

EXPERIMENTAL

Restoration using a low-cost sealant

Procedure: Low Cost

Interventions

High costPROCEDURE

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

High Cost

Low CostPROCEDURE

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.

Low Cost

Eligibility Criteria

Age4 Years - 9 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Faculty Sao Leopoldo Mandic Campinaslead

Study Sites (1)

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, Brazil

RECRUITING

Related Publications (5)

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.
PMID: 24884684RESULT
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.
PMID: 19761288RESULT
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.
PMID: 18709230RESULT
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
PMID: 3344163RESULT
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.
PMID: 22023543RESULT

MeSH Terms

Conditions

Dental CariesVan der Woude syndrome

Interventions

Technology, High-Cost

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Technology Assessment, BiomedicalHealth Care Economics and Organizations

Central Study Contacts

Jose Carlos P Imparato, PhD

CONTACT

+5511998686008 jimparato@usp.br

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PhD, Senior Lecturer, Clinical Professor

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 29, 2019

Study Start

August 15, 2017

Primary Completion

February 15, 2019

Study Completion

December 1, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

BR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

High Cost

Low Cost

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations