Selective Dentine Removal in Primary Teeth

Not Applicable

Completed

• Conditions: Caries, Dental
• Interventions: Procedure: Selective removal of carious tissue and restoration with Maxxion; Procedure: Control

• Registration Number: NCT03872037
• Lead Sponsor: Faculty Sao Leopoldo Mandic Campinas

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-02
• Primary Completion: 2016-02-03
• Study Completion: 2017-02-03
• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-09
• Study First Posted: 2019-03-12
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selective removal of caries and restoration with Maxxion	Selective removal of carious tissue and restoration with Maxxion	Molars subjected to selective removal and restored with Maxxion
Control	Control	Molars subjected to selective removal and restored with Ketac Molar Easymix

Primary Outcome Measures

Name	Time	Method
Number of teeth with treatment-related success as assessed by radiographic analysis.	24-month	To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.

Trial Locations

Locations (1)

Faculty Sao Leopoldo Mandic; 🇧🇷 Campinas, Sao Paulo, Brazil