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

NCT03785730 | Suspended

• 1 other identifier: Unib3
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Tooth survival by clinical assessment

  Comparing the survival of teeth treated with restoration of resin composite and with NRCC for lesions cavitated in anterior primary teeth by clinical assessment, considering as success when the teeth will be without clinical signs or symptoms of pulp pathology or exfoliated, with no need for more invasive interventions, such as pulpectomy or extraction.

  24 months

Secondary Outcomes (4)

• Discomfort regarding the treatment options by a Face image scale (FIS)

  Immediately after treatment

• Cost-effectiveness analysis

  24 months.

• Perception of parents / guardians evaluated through questionnaire

  Prior to treatment, immediately after and 6 months later.

• Satisfaction of children: questionnaire

  After 6 months

Study Arms (2)

Non-restorative cavity control - NRCC

EXPERIMENTAL

Enlargement with metallic sandpaper associated with toothbrushing/1000 ppm fluoride toothpaste.

Procedure: Non-restorative cavity control - NRCC group

Resin composite restoration - RCR

ACTIVE COMPARATOR

Selective carious lesion removal and restoration with resin composite.

Procedure: Restoration with resin composite - RCR group

Interventions

Non-restorative cavity control - NRCC group PROCEDURE

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

Non-restorative cavity control - NRCC

Restoration with resin composite - RCR group PROCEDURE

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.

Resin composite restoration - RCR

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children will be included that have at least one anterior tooth with carious lesion cavitated affecting the proximal surface.

You may not qualify if:

• Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
• Also, teeth with lesions affecting more than one third of the buccal/lingual surfaces, with previous history of dental trauma, presenting pulp exposure, spontaneous pain, pathological mobility, presence of abscess or fistula next to the tooth, teeth with restorations, developmental enamel defects or physiological mobility (exfoliation) will be excluded.

Sponsors & Collaborators

• Universidade Ibirapuera: lead

Study Sites (1)

Tamara Kerber Tedesco

São Paulo, São Paulo, 04.545-000, Brazil

Location

Related Publications (1)

• Bianchi RMD, Pascareli-Carlos AM, Floriano I, Raggio DP, Braga MM, Gimenez T, Holanda MC, da Silva GS, de Natal KH, Tedesco TK. 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. BMC Oral Health. 2021 Mar 31;21(1):167. doi: 10.1186/s12903-021-01524-0.

  PMID: 33789643 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 24, 2018
• Study Start: April 30, 2019
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)