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

NCT02903979 | Completed

• 1 other identifier: UNIB1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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%.

Conditions

Deep Caries Lesion of Primary Teeth

Outcome Measures

Primary Outcomes (1)

• Pulp Vitality

  To evaluate the survival of different restorative treatments considering the pulp vitality.

  Up to 24 months

Secondary Outcomes (4)

• Wong-Baker scale to discomfort

  Immediately to restoration procedure.

• Cost-efficacy analysis by total value of treatment in relation to efficacy

  Up to 24 months

• Restoration longevity

  Up to 24 months.

• Caries progression

  Up to 24 months.

Study Arms (2)

HVGIC

EXPERIMENTAL

Restorations with only HVGIC in deep caries lesion of primary teeth.

Other: HVGIC

Indirect pulp capping

ACTIVE COMPARATOR

Indirect pulp capping with calcium hydroxide cement, restored with HVGIC:

Other: Indirect pulp capping

Interventions

HVGIC OTHER

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.

HVGIC

Indirect pulp capping OTHER

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.

Indirect pulp capping

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Universidade Ibirapuera: lead

Study Sites (1)

Universidade Ibirapuera

São Paulo, São Paulo, 04661-100, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30621659 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Pediatric Dentistry

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 16, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

BR (1)