Trial | NCT02338180  Report issue

Title

Preventive and Therapeutic Proximal Sealants
A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    390
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.
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 Started
Mar 31
2009
Primary Completion
Nov 30
2012
Study Completion
Nov 30
2012
Last Update
Sep 27
2016
Estimate

Other proximal preventive sealants

On sound mesial surfaces of first permanent molars adjacent to a caries active lesion of second primary molar, after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage.

  • Other names: Concise Sealant (3M ESPE)

Other proximal therapeutic sealant

On mesial surfaces of first permanent molars with caries active lesion adjacent to a caries active lesion of second primary molar , after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage.

  • Other names: Concise Sealant (3M ESPE)

Control group A No Intervention

Children with no caries lesion on adjacent surfaces of second primary molar and first permanent molar

Group B Preventive sealant Experimental

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

Group C Therapeutic sealant Experimental

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

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
No Results Posted