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Preventive and Therapeutic Proximal Sealants (PTPS)

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
proximal preventive sealants
proximal therapeutic sealant
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring dental caries, risk assessment, approximal sealant, permanent molar, preventive dentistry, adolescent

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dental Reference Center Simon Bolivar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group A

Group B Preventive sealant

Group C Therapeutic sealant

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2015
Last Updated
September 23, 2016
Sponsor
Universidad de Valparaiso
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02338180
Brief Title
Preventive and Therapeutic Proximal Sealants
Acronym
PTPS
Official Title
A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso
Collaborators
Göteborg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, risk assessment, approximal sealant, permanent molar, preventive dentistry, adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group A
Arm Type
No Intervention
Arm Description
Children with no caries lesion on adjacent surfaces of second primary molar and first permanent molar
Arm Title
Group B Preventive sealant
Arm Type
Experimental
Arm Description
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
Arm Title
Group C Therapeutic sealant
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
proximal preventive sealants
Other Intervention Name(s)
Concise Sealant (3M ESPE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
proximal therapeutic sealant
Other Intervention Name(s)
Concise Sealant (3M ESPE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of active lesion developed on first molar mesial surfaces
Description
Outcome will be measured by a radiographical examination (standardized posterior bitewings) 3.5 years after the preventive or therapeutical proximal sealants have been applied.
Time Frame
3.5 years (42-44 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian P Basili, DDS, PHD
Organizational Affiliation
University of Valparaiso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Reference Center Simon Bolivar
City
Viña del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520000
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
22257664
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.
Results Reference
background
PubMed Identifier
25066832
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.
Results Reference
result
PubMed Identifier
16167153
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.
Results Reference
result

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Preventive and Therapeutic Proximal Sealants

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