NCT03785730

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

Impact of Non-restorative Cavity Control on Proximal Carious Lesions of Anterior Primary Teeth on the Tooth Survival and Patient-centered Outcomes (CEPECO 2) - Study Protocol for a Non-inferiority Randomized Clinical Trial

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Universidade Ibirapuera · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

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%.

Detailed description

This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1 allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera (UNIB). The other centers involved are considered co-participants (Centro Universitário do Norte - Uninorte , Centro Universitário Uninovafapi - UNINOVAFAPI, and School of Dentistry from the University of Sao Paulo - FOUSP). Children aged 3 to 6 years with at least one proximal cavitated lesion on anterior primary teeth will be selected from the Clinical Pediatric Research Center. Teeth will be randomly allocated to selective removal of carious tissue and resin composite restoration (RCR) or NRCC. Tooth survival after two years of follow-up will be the primary outcome and cost-effectiveness, satisfaction, and discomfort reported by participants and parents/guardians' perception will be the secondary outcomes. Only patients who fulfill the eligibility criteria will be included in the study after the legal guardians sign the informed consent form and the child consents to participate in the study.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-30
• Primary completion: 2025-12-30
• Completion: 2027-12-30
• First posted: 2018-12-24
• Last updated: 2024-05-10

Locations

1 site across 1 country: Brazil