Preventive and Therapeutic Proximal Sealants

Dental Caries Clinical Trial

— PTPS  

Official title:

A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338180
• Other study ID #: Project DIPUV 30/2007
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2015
• Last updated: September 23, 2016
• Start date: March 2009
• Est. completion date: November 2012

Study information

• Verified date: September 2016
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Dental Reference Center Simon Bolivar	Viña del Mar	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Göteborg University

Country where clinical trial is conducted

Chile, 

References & Publications (3)

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 Den — View 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. Epub 2005 Sep 16. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of active lesion developed on first molar mesial surfaces	Outcome will be measured by a radiographical examination (standardized posterior bitewings) 3.5 years after the preventive or therapeutical proximal sealants have been applied.	3.5 years (42-44 months)	No