Sealing Microcavitated Carious Lesions

NCT02849925 | Completed

• 1 other identifier: RCTICDAS3/2015
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent molars may be arrested by sealing using two different types of materials; a glass ionomer and a resin sealant. A Randomized controlled clinical trial was designed. Children between 6 and 12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars were allocated to one of the two arms of the study. Clinical and radiographic lesion progression were the main outcome. Integrity of the material and retention were secondary outcomes. A follow up period of 24 months with check-ups at 6 and 12 months was considered.

Conditions

Dental Caries

Keywords

Pit and Fissure Sealants; Caries; Glass ionomer; Resin

Outcome Measures

Primary Outcomes (1)

• Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions.

  ICDAS 3 lesions will be followed and monitored for clinical and radiographic progression

  24 months

Secondary Outcomes (2)

• Percentage of sealants that were intact from the first intervention over time.

  24 months

• Percentage of sealants that were fractured or lost during the follow-up.

  24 months

Study Arms (2)

Glass Ionomer Sealant

EXPERIMENTAL

Sealants to arrest microcavitated caries. 75 microcavitated ICDAS 3 lesions will be sealed by the use of Glass ionomer sealant, EQUIA (GC) in first permanent molars.

Drug: Sealants to arrest microcavitated caries.

Resin Sealant

ACTIVE COMPARATOR

Sealants to arrest microcavitated caries. 75 microcavitated ICDAS 3 lesions will be sealed by the use of resin sealant, Clinpro (3M-ESPE) in first permanent molars

Drug: Sealants to arrest microcavitated caries.

Interventions

Sealants to arrest microcavitated caries. DRUG

Carious lesions will be treated by minimally invasive dentistry by the use of sealants instead of eliminating carious tissues and using conventional restorative materials.

Also known as: Carious lesion arrest

Glass Ionomer Sealant; Resin Sealant

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• To have at least one ICDAS 3 lesion in first permanent molars
• To be systemically healthy

You may not qualify if:

• Not fully erupted first molars
• Structural defects in first molars, i.e., hypoplasia, fluorosis, MIH.
• Periodontal disease
• Orthodontic appliances
• Medication use

Sponsors & Collaborators

• University of Talca: lead

Study Sites (1)

Faculty of Health Sciences

Talca, No State, 3460000, Chile

Location

Related Publications (1)

• Munoz-Sandoval C, Gambetta-Tessini K, Giacaman RA. Microcavitated (ICDAS 3) carious lesion arrest with resin or glass ionomer sealants in first permanent molars: A randomized controlled trial. J Dent. 2019 Sep;88:103163. doi: 10.1016/j.jdent.2019.07.001. Epub 2019 Jul 2.

  PMID: 31276747 DERIVED

MeSH Terms

Conditions

Dental Caries; Van der Woude syndrome

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 29, 2016
• Study Start: March 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)