A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Universidad de Valparaiso
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- Number of active lesion developed on first molar mesial surfaces
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 8 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group A
Children with no caries lesion on adjacent surfaces of second primary molar and first permanent molar
Group B Preventive sealant
Children with active caries lesion on distal surfaces of second primary molar and sound mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received a proximal preventive sealants, and the other remain as a control
Intervention: proximal preventive sealants (Other)
Group C Therapeutic sealant
Children with active caries lesion on distal surfaces of second primary molar and active lesion on mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received proximal therapeutic sealant, and the other remain as a control
Intervention: proximal therapeutic sealant (Other)
Group C Therapeutic sealant
Children with active caries lesion on distal surfaces of second primary molar and active lesion on mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received proximal therapeutic sealant, and the other remain as a control
Intervention: proximal preventive sealants (Other)
Outcomes
Primary Outcomes
Number of active lesion developed on first molar mesial surfaces
Time Frame: 3.5 years (42-44 months)
Outcome will be measured by a radiographical examination (standardized posterior bitewings) 3.5 years after the preventive or therapeutical proximal sealants have been applied.
Secondary Outcomes
No secondary outcomes reported
Investigators
CRISTIAN BASILI
DDS, PhD, Associate Professor
Universidad de Valparaiso