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

Not Applicable

Completed

• Conditions: Deep Caries Lesion of Primary Teeth
• Interventions: Other: Indirect pulp capping; Other: HVGIC

• Registration Number: NCT02903979
• Lead Sponsor: Universidade Ibirapuera

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Study Start: 2016-11
• Primary Completion: 2018-03
• Study Completion: 2020-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indirect pulp capping	Indirect pulp capping	Indirect pulp capping with calcium hydroxide cement, restored with HVGIC:
HVGIC	HVGIC	Restorations with only HVGIC in deep caries lesion of primary teeth.

Primary Outcome Measures

Name	Time	Method
Pulp Vitality	Up to 24 months	To evaluate the survival of different restorative treatments considering the pulp vitality.

Secondary Outcome Measures

Name	Time	Method
Wong-Baker scale to discomfort	Immediately to restoration procedure.	To evaluate the discomfort of different restorative treatments by a Wong-Baker scale.
Cost-efficacy analysis by total value of treatment in relation to efficacy	Up to 24 months	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.
Restoration longevity	Up to 24 months.	To evaluate the restoration longevity by clinical examination.
Caries progression	Up to 24 months.	To evaluate the caries progression by radiography.

Trial Locations

Locations (1)

Universidade Ibirapuera; 🇧🇷 São Paulo, SP, Brazil