Clinical trial NCT02338180: Preventive and Therapeutic Proximal Sealants
Official title: A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: dental caries
risk assessment
approximal sealant
permanent molar
preventive dentistry
adolescent
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2015-01-14
Enrollment: 390
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is of clinical importance to arrest the development of approximal caries at an early stage. The potential for initial caries to develop into manifest lesions has motivated studies on the use of sealants to arrest the progression of caries on both occlusal and approximal tooth surfaces.

Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested here was that preventive and therapeutic sealants do not prevent the development or slow the progression of dental caries over a period of 3.5 years in comparison to non-sealed control surfaces.

Detailed description: The study population comprised 121 schoolchildren aged 8 to 10 years in a high-caries community in Valparaiso, Chile. They were examined clinically and radiographically, divided into 3 groups, and treated accordingly: children in Group A had no carious lesions on the approximal surfaces of 05d-6m and received no sealants; those in group B had active caries on 05d and received a preventive sealant on the caries-free 6m; and those in group C had active caries on 05d with an initial active lesion on 6m and received a therapeutic sealant on 6m. After 3.5 years, standardized follow-up radiographs were obtained for the children that remained.

Eligibility criteria: Inclusion Criteria:

* children with high rate of caries in the primary dentition
* active caries on the distal surfaces of the second primary molars at least on both sides of the mouth
* children with no lesions on the adjacent tooth surfaces on the second primary and first permanent molars were included as a general control group

Exclusion Criteria:

* children using medication containing sucrose or with a negative effect on salivary flow
* children using orthodontic devices
* children who refuses to participate

Primary outcomes:
measure: Number of active lesion developed on first molar mesial surfaces
timeFrame: 3.5 years (42-44 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Viña del Mar
country: Chile
facility: Dental Reference Center Simon Bolivar
state: Valparaiso
Study officials:
affiliation: University of Valparaiso
name: Cristian P Basili, DDS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.
citation: Ammari MM, Soviero VM, da Silva Fidalgo TK, Lenzi M, Ferreira DM, Mattos CT, de Souza IP, Maia LC. Is non-cavitated proximal lesion sealing an effective method for caries control in primary and permanent teeth? A systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1217-27. doi: 10.1016/j.jdent.2014.07.015. Epub 2014 Jul 24.
citation: Gomez SS, Basili CP, Emilson CG. A 2-year clinical evaluation of sealed noncavitated approximal posterior carious lesions in adolescents. Clin Oral Investig. 2005 Dec;9(4):239-43. doi: 10.1007/s00784-005-0010-7. Epub 2005 Sep 16.