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Non-restorative Cavity Control in Anterior Cavitated Caries Lesion of Primary Teeth

NCT03785730 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-05-10

No results posted yet for this study

Summary

Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes. Methods: A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18, and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants' satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%.

Conditions

  • Dental Caries

Interventions

PROCEDURE

Non-restorative cavity control - NRCC group

The proximal cavities will be enlarged with metallic sandpaper, exposing the cavity, to allow access for toothbrushing associated with 1000 ppm fluoride toothpaste.

PROCEDURE

Restoration with resin composite - RCR group

In control group, the treatment will be performed after prophylaxis and relative isolation. The selective carious tissue removal will be performed with appropriate dentin curettes. The acid conditioning will be performed only in enamel for 15 s with 37% phosphoric acid gel, and then the application of the adhesive system and restoration of resin composite will be conducted.

Sponsors & Collaborators

  • Universidade Ibirapuera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2025-12-30
Completion
2027-12-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785730 on ClinicalTrials.gov