Selective Dentine Removal in Primary Teeth

Faculty Sao Leopoldo Mandic Campinas

Status: Completed

Conditions: Caries, Dental

Treatments: Procedure: Selective removal of carious tissue and restoration with Maxxion; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03872037

SLM 7

Details and patient eligibility

About

Background There is little information regarding the longevity of the restored tooth, considering the health of the pulp-dentine complex, in children who do not sufficiently cooperate with dental treatment.

Aim To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.

Design A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).

Enrollment: 150 patients

Sex: All

Ages: 4 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• An active denture caries lesion
• The molars in primary, without anterior restoration, with the exclusive involvement of occlusal and mesial or distal surfaces present (International Caries Detection and Evaluation System, ICDAS score 5)

Exclusion criteria

• Those who did not accept care after 3 adaptation sessions
• Teeth with the following characteristics were excluded from the study: spontaneous pain, pressure sensitivity, suspected cellulose involvement, necrosis pulp, fistula, or tooth mobility
• Teeth in which extension of the lesion could lead to pulpal exposure were excluded
• Children whose parents or guardians do not sign an Informed Consent Term

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Control

Active Comparator group

Description:

Molars subjected to selective removal and restored with Ketac Molar Easymix

Treatment:

Procedure: Control

Selective removal of caries and restoration with Maxxion

Experimental group

Description:

Molars subjected to selective removal and restored with Maxxion

Treatment:

Procedure: Selective removal of carious tissue and restoration with Maxxion