NCT02232828

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

August 29, 2014

Last Update Submit

July 27, 2015

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Success (re-intervention required no/yes)

    The primary outcome of the study will be success (i. e. not requiring any re-intervention).

    36 month

Secondary Outcomes (6)

  • Survival (tooth removal required no/yes)

    36 months

  • Restoration integrity (scored as alpha, beta, gamma, delta)

    36 months

  • Patients' subjective assessment of the treatment (0-10)

    0 months (directly after treatment)

  • Dentists' subjective assessment (1-6)

    0 months (directly after treatment)

  • Parents' subjective assessment (1-6)

    0 months (directly after treatment)

  • +1 more secondary outcomes

Study Arms (2)

Selective removal

EXPERIMENTAL
Procedure: Selective removal

Stepwise removal

ACTIVE COMPARATOR
Procedure: Stepwise removal

Interventions

Selective removalPROCEDURE

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.

Selective removal
Stepwise removalPROCEDURE

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.

Stepwise removal

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 3-9 yr
  • Good general health
  • Minimum one active deep (D3) occlusal/occlusal-proximal, one-/two-surface caries lesion

You may not qualify if:

  • Participating in other study
  • Plan to move or not resident
  • Systemic disease or general disability
  • Expected limited compliance
  • Known allergy to study material expected exfoliation within 18 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ernst-Moritz-Arndt University of Greifswald, Präventive Zahnmedizin und Kinderzahnheilkunde

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

NOT YET RECRUITING

Uniklinik RWTH Aachen; Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin, Abteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin

Berlin, State of Berlin, 14197, Germany

RECRUITING

CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin; Abteilungen für Zahnerhaltung und Präventive Zahnheilkunde

Berlin, State of Berlin, 14197, Germany

RECRUITING

Related Publications (3)

  • Elhennawy K, Finke C, Paris S, Reda S, Jost-Brinkmann PG, Schwendicke F. Selective vs stepwise removal of deep carious lesions in primary molars: 24 months follow-up from a randomized controlled trial. Clin Oral Investig. 2021 Feb;25(2):645-652. doi: 10.1007/s00784-020-03536-6. Epub 2020 Aug 28.

    PMID: 32857210DERIVED

  • Elhennawy K, Finke C, Paris S, Reda S, Jost-Brinkmann PG, Schwendicke F. Selective vs stepwise removal of deep carious lesions in primary molars: 12-Months results of a randomized controlled pilot trial. J Dent. 2018 Oct;77:72-77. doi: 10.1016/j.jdent.2018.07.011. Epub 2018 Jul 17.

    PMID: 30025748DERIVED

  • Schwendicke F, Schweigel H, Petrou MA, Santamaria R, Hopfenmuller W, Finke C, Paris S. Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial. Trials. 2015 Jan 6;16:11. doi: 10.1186/s13063-014-0525-9.

    PMID: 25560779DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Falk Schwendicke, OA Dr.

    Chatrite Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Sebastian Paris, Prof. Dr.

    Charite Berlin, Germany

    STUDY CHAIR

  • Christian Finke, OA Dr.

    Charite Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Marina A. Petrou, Dr.

    Uniklinic RWTH Aachen, Germany

    PRINCIPAL INVESTIGATOR

  • Christian Spleith, Prof. Dr.

    University Greifswald, Germany

    PRINCIPAL INVESTIGATOR

  • Ruth Santamaria, Dr.

    University Greifswald, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Falk Schwendicke, OA Dr.

CONTACT

+4930450562falk.schwendicke@charite.de

Sebastian Paris, Prof. Dr.

CONTACT

+4930450562

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OA Dr.

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 5, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2017

Study Completion

June 1, 2018

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

DE(4)