Preventive and Therapeutic Proximal Sealants

NCT02338180 | Completed Phase 4 DMC

• 1 other identifier: Project DIPUV 30/2007
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

dental caries; risk assessment; approximal sealant; permanent molar; preventive dentistry; adolescent

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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

Other: proximal preventive sealants

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

Other: proximal preventive sealants; Other: proximal therapeutic sealant

Interventions

proximal preventive sealants OTHER

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.

Also known as: Concise Sealant (3M ESPE)

Group B Preventive sealant; Group C Therapeutic sealant

proximal therapeutic sealant OTHER

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.

Also known as: Concise Sealant (3M ESPE)

Group C Therapeutic sealant

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Göteborg University: collaborator

Study Sites (1)

Dental Reference Center Simon Bolivar

Viña del Mar, Región de Valparaíso, 2520000, Chile

Location

Related Publications (3)

• 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.

  PMID: 22257664 BACKGROUND

• 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.

  PMID: 25066832 RESULT

• 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.

  PMID: 16167153 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cristian P Basili, DDS, PHD

  University of Valparaiso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Associate Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: March 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CL (1)