Selective Dentine Removal in Primary Teeth

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).

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Key information

Conditions

Caries, Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selective removal of carious tissue and restoration with Maxxion

Procedure

Molars subjected to selective removal and restored with Maxxion

Control

Procedure

Molars subjected to selective removal and restored with Ketac Molar Easymix

Primary outcomes

Number of teeth with treatment-related success as assessed by radiographic analysis.

Time frame: 14-month

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Faculty Sao Leopoldo Mandic Campinas

Other

Registry information

Official study title

Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Mar 12, 2019
Registry last updated: Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed