Skip to main content
OpenTrials
Completed

NCT Number: NCT02338180

Preventive and Therapeutic Proximal Sealants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental Reference Center Simon Bolivar

Viña del Mar, Valparaiso, 2520000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Concise Sealant (3M ESPE)

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.

Other names: Concise Sealant (3M ESPE)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Collaborators

  • Göteborg University

Registry information

Official study title

A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants

Acronym: PTPS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2015
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.