Primary Molars Restorations With Encapsulated or Hand-Mixed Glass Ionomer: Clinical Trial

NCT ID: NCT02274142

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-10-31

Brief Summary

The aim of this RCT is to evaluate the survival of different glass ionomer cement in minimally invasive restorations, with different handling characteristics: hand-mixed versus encapsulated.

Detailed Description

Detailed Description: This study was approved by the research ethics committee of the School of Dentistry (University of São Paulo, Brazil) and written informed consent will be obtained from the parents or legal guardians. The sample size was calculated based on the data obtained in a systematic review, which reported average longevity of 78% after 2 years of follow up (mean survival of occlusal and occlusoproximal surfaces). The minimum difference of 15% in the success rate between the control and treatment groups after 2 years of follow-up, with and α of 5% and power (strength) of 80% using paired test. As more than one tooth per children might be included, we must add a 20% for clustering. Adding 20% for possible losses the final estimate is 116 teeth per group, reaching a final sample of 232 teeth.

Inclusion Criteria:

• Children who have sought treatment in the School of Dentistry, University of Sao Paulo;
• Children between 3 and 10 years old without systemic diseases;
• Children presenting at least one dentin caries cavity in primary teeth (occlusal or oclusoproximal) with no signs of pulp involvement.

Exclusion Criteria:

• Children whose parents did not agree to participate in the study;
• Children with behavioural issues at the initial exam or who did not assent to participate in the study.

Implementation:

All the occlusal and occlusoproximal restorations will be performed by two operators on the dental chair. The operators will be assisted by another dentist, who will be previously trained to mix the GIC according to the manufacturers' protocol. The children will be randomly assigned into two groups: Hand-mixed and encapsulated materials.

Treatment procedure:

The restorative technique will be performed according to the Minimal Intervention Dentistry. No local anaesthesia will be used during treatment. Rotary instruments can be used to open or to expand the cavity opening, removing only enamel. Infected carious dentin will be removed with hand instruments. The use of hand instruments on the dentin surface results in a smear layer and need to be removed by the use of dentine conditioner. The liquid component of the hand-mixed powder-liquid GIC, containing the acid component, will be used and saliva isolation will be done with cotton wool rolls. The cavities will be restored with one of the two GIC brands: Fuji IX (GC Europe, Leuven, BE) and EQUIA (GC Europe, Leuven, BE). A thin layer of petroleum jelly will be rubbed over the index finger and the restoration will be pressed for 20 seconds. The material will include sealing pits and the fissure. After preparing for a balanced occlusion, a new layer of petroleum jelly will be applied to the GIC restoration. The amount of GIC used, element number, cavity dimension and dmft will be recorded. The duration of the restorative procedure will be recorded with a stopwatch. The participating children will be instructed not to eat for one hour after the restoration is placed.

Evaluation:

The success of the restorations will be evaluated after 6 months according to the Frencken and Holmgren criteria for occlusal surfaces, and modified version of Roeleveld et al. (2006) criteria for occlusoproximal surfaces. A restoration will be considered as 'failure' when there is a defect in the filling when secondary caries is observed, when the restoration is not present or when the pulp is inflamed. When the restoration is still present or a slight defect is observed, it will be considered as 'success'. When the tooth is unavailable for evaluation, it will be censored. All evaluations will be carried out by two independent evaluators, who did not restore the cavities, trained and calibrated by a benchmark.

Estimation of cost-effectiveness:

The material cost (GICs) will be estimated per restoration. The average cost per restoration will be estimated. Costs of equipment, autoclave and hand instruments, disposables (hand gloves, face masks, cotton wool rolls), articulating paper and petroleum jelly used for the restorations are equal for both GIC groups and will be excluded. There will be no labour costs for the operators.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Restorations with Encapsulated material

Restorations performed with encapsulated glass ionomer cement (EQUIA - GC Corp). Capsules with glass ionomer will be activated and applied after selective carious tissue removal in primary molars.

Group Type: EXPERIMENTAL

Restoration with Encapsulated material

Intervention Type: PROCEDURE

restoration with encapsulated ionomer cement

Encapsulated glass ionomer cement (EQUIA - GC Corp).

Intervention Type: DEVICE

Restorations with Hand-Mixed material

Restorations will be performed with hand-mixed glass ionomer cement (Fuji IX - GC Corp) after selective carious tissue removal in primary molars.

Group Type: ACTIVE_COMPARATOR

Restoration with hand-mixed material

Intervention Type: PROCEDURE

restoration with hand-mixed glass ionomer cement

powder-liquid glass ionomer cement (Fuji IX - GC Corp)

Intervention Type: DEVICE

Interventions

Restoration with hand-mixed material

restoration with hand-mixed glass ionomer cement

Intervention Type: PROCEDURE

Restoration with Encapsulated material

restoration with encapsulated ionomer cement

Intervention Type: PROCEDURE

Encapsulated glass ionomer cement (EQUIA - GC Corp).

Intervention Type: DEVICE

powder-liquid glass ionomer cement (Fuji IX - GC Corp)

Intervention Type: DEVICE

Other Intervention Names

Minimally invasive restoration

Eligibility Criteria

Inclusion Criteria

• Children who have sought treatment in the School of Dentistry, University of Sao Paulo;
• Children between 3 and 10 years old without systemic diseases;
• Children presenting at least one dentin caries cavity in primary teeth (occlusal or oclusoproximal) with no signs of pulp involvement.

Exclusion Criteria

• Children whose parents did not agree to participate in the study;
• Children with behavioural issues at the initial exam or who did not assent to participate in the study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Daniela Prócida Raggio

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Raggio, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

References

Oliveira RC, Camargo LB, Novaes TF, Pontes LRA, Olegario IC, Gimenez T, Passaro AL, Tedesco TK, Braga MM, Mendes FM, Raggio DP. Survival rate of primary molar restorations is not influenced by hand mixed or encapsulated GIC: 24 months RCT. BMC Oral Health. 2021 Jul 23;21(1):371. doi: 10.1186/s12903-021-01710-0.

Reference Type: DERIVED

PMID: 34301217 (View on PubMed)

Other Identifiers

MICARDEC

Identifier Type: -

Identifier Source: org_study_id