Selective Dentine Removal in Primary Teeth

Not Applicable

Completed

• Conditions: Caries, Dental

• 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

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