Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth

In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.

Study Overview

• Status: Completed
• Conditions: Deep Caries Lesion of Primary Teeth
• Intervention / Treatment: Other: HVGIC; Other: Indirect pulp capping

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04661-100
      • Universidade Ibirapuera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children will be included that have at least one primary molar with deep cavitated carious lesions in occlusal surface.

Exclusion Criteria:

• Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity. Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HVGIC; Restorations with only HVGIC in deep caries lesion of primary teeth.	Other: HVGIC; In experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion.
Active Comparator: Indirect pulp capping; Indirect pulp capping with calcium hydroxide cement, restored with HVGIC:	Other: Indirect pulp capping; In control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulp Vitality	To evaluate the survival of different restorative treatments considering the pulp vitality.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong-Baker scale to discomfort	To evaluate the discomfort of different restorative treatments by a Wong-Baker scale.	Immediately to restoration procedure.
Cost-efficacy analysis by total value of treatment in relation to efficacy	To evaluate the cost-efficacy of different restorative treatments by total value in dollar of treatment in relation to efficacy. The researchers would like to analyze that a treatment of low cost show the similar efficacy of a high cost treatment.	Up to 24 months
Restoration longevity	To evaluate the restoration longevity by clinical examination.	Up to 24 months.
Caries progression	To evaluate the caries progression by radiography.	Up to 24 months.

Collaborators and Investigators

• Sponsor: Universidade Ibirapuera

Publications and helpful links

General Publications

• da Silva GSQ, Raggio DP, Machado GFR, Mello-Moura ACV, Gimenez T, Floriano I, Tedesco TK. Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial. BMC Oral Health. 2019 Jan 8;19(1):6. doi: 10.1186/s12903-018-0703-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UNIB1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No