Selective or Stepwise Removal of Deep Caries

Summary

Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step incomplete excavation seems advantageous compared with complete caries removal. However, current evidence regarding the success, as defined by not requiring any re-treatments, or survival of teeth after different excavations is insufficient for definitive recommendation, especially when treating deciduous teeth. Moreover, restoration integrity has not been comparatively analyzed longitudinally, and neither patients', dentists' or parents' preferences nor the clinical long-term costs emanating from both initial and re-treatments have been reported yet.

Our primary hypothesis is that success rates differ significantly between selectively and stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to significantly differ between selectively and stepwise excavated teeth.

Conditions

• Dental Caries

Interventions

PROCEDURE

Selective removal

Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.

PROCEDURE

Stepwise removal

Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used. If allocated to stepwise excavation, the second excavation will now be performed as described until only hard, dry dentin remains. Restoration will again be provided adhesively as described.

Sponsors & Collaborators

• Rheinisch-Westfälische Technische Hochschule RWTH Aachen, Germany

  collaborator UNKNOWN

• University Medicine Greifswald

  collaborator OTHER

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Falk Schwendicke, OA Dr. · Chatrite Berlin, Germany

• Sebastian Paris, Prof. Dr. · Charite Berlin, Germany

• Christian Finke, OA Dr. · Charite Berlin, Germany

• Marina A. Petrou, Dr. · Uniklinic RWTH Aachen, Germany

• Christian Spleith, Prof. Dr. · University Greifswald, Germany

• Ruth Santamaria, Dr. · University Greifswald, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2017-10-31

Completion

2018-06-30

Countries

• Germany

Study Locations