Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

NCT04127357 | Completed

• 1 other identifier: SLM 8
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Methodology: We selected 22 children from 4 to 9 years old from the public school system of the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS). Randomization was performed en bloc and stratified by two conditions (age and caries experience). The selected teeth were divided into two groups: the first (G1) was submitted to brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. The molars undergoing treatment were evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type of treatment, dental group and sealant retention by the Chi-square test. For cost analysis, the variance test (ANOVA) was used.

Conditions

Dental Caries in Children; Pit and Fissure Sealant; Toothbrushing

Keywords

Pit and fissure sealants; Pediatric dentistry; Toothbrushing

Outcome Measures

Primary Outcomes (2)

• Clinical evaluation of caries progression

  With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.

  6 months

• Clinical evaluation of caries progression

  With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.

  12 months

Secondary Outcomes (2)

• Sealant retention

  6 months

• Sealant retention

  12 months

Other Outcomes (2)

• Direct cost estimate

  6 months

• Direct cost estimate

  12 months

Study Arms (2)

A - Control

OTHER

Brushing with 1450 ppm fluoride toothpaste.

Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).

B - Test

EXPERIMENTAL

Resin sealing (FluroShield, Dentsply, Brazil).

Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).

Interventions

1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). PROCEDURE

After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil). The teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months.

A - Control; B - Test

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At least one primary molar with active caries lesions classified as ICDAS score 3.

You may not qualify if:

• Children with differentiated management needs and/or systemic diseases with oral involvement.
• Primary molar with active caries lesions classified as ICDAS score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.

Sponsors & Collaborators

• Faculty Sao Leopoldo Mandic Campinas: lead

Related Publications (2)

• Meyer-Lueckel H, Paris S. When and How to Intervene in the Caries Process. Oper Dent. 2016 Sep;41(S7):S35-S47. doi: 10.2341/15-022-O.

  PMID: 27689929 RESULT

• Bakhshandeh A, Qvist V, Ekstrand KR. Sealing occlusal caries lesions in adults referred for restorative treatment: 2-3 years of follow-up. Clin Oral Investig. 2012 Apr;16(2):521-9. doi: 10.1007/s00784-011-0549-4. Epub 2011 Apr 9.

  PMID: 21479565 RESULT

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

CMW cement

Study Officials

• Jose Carlos P Imparato, PhD

  Sao Leopoldo Mandic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Lecturer, Clinical Professor

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: October 15, 2019
• Study Start: March 5, 2015
• Primary Completion: September 1, 2016
• Study Completion: August 12, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share