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Selective or Stepwise Removal of Deep Caries

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ClinicalTrials.gov Identifier: NCT02232828
Recruitment Status : Unknown
Verified July 2015 by Falk Schwendicke, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 5, 2014
Last Update Posted : July 28, 2015
Sponsor:
Collaborators:
Rheinisch-Westfälische Technische Hochschule RWTH Aachen, Germany
University Medicine Greifswald
Information provided by (Responsible Party):
Falk Schwendicke, Charite University, Berlin, Germany

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.


Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Selective removal Procedure: Stepwise removal Not Applicable

Detailed Description:

The treatment of deep caries lesions is associated with significant risks for the pulp, including pulpal exposure and post-operative pulpal complications, which might eventually compromise the retention of the tooth [1]. Moreover, treating deep lesions might be associated with pain and subjective burden both during and after treatment and might generate long-term costs due to re-treatments being required [2, 3].

For deciduous teeth, various treatments for deep lesions have been described: Complete excavation aims at removing all infected and affected carious dentin, with the inherent risk of pulpal exposure. In contrast, stepwise, i. e. two-step excavation leaves carious dentin after the initial excavation step, then seals residual caries under a temporary restoration, and re-enters the cavity in a second step to eventually attempt complete excavation. This approach is thought to facilitate arrest and remineralization of the lesion and to induce development of tertiary dentin, thereby reducing the risk of pulpal exposure and post-operative complications after the second excavation step [4, 5]. Since several studies found sealed residual lesions to be clinically and microbiologically arrested, the need to re-enter was increasingly questioned within the last decade [6]. Selective, i. e. one-step incomplete or partial excavation seals carious dentin under a definitive restoration, omitting any re-entry [7]. Sealing the lesion is thought to deprive residual bacteria from dietary carbohydrates and was found to exert significant antibacterial effects, thus arresting the lesion [8, 9].

However, doubts remain regarding the effects of sealed carious dentin on the long-term quality of the restoration [10]. Moreover, it remains unknown if patients prefer one of both treatments, which might be especially relevant when treating children. Several studies comparing complete with selective or stepwise excavation of deciduous teeth have been published, but only one three-arm study compared selective with stepwise excavation of primary teeth (Tab. 1). In addition, none of these studies assessed patient- or dentists-centered outcomes, i. e. preferences, or analyzed clinically assessed long-term costs emanating from both excavations.

Objectives and Hypotheses The study aims at comparing the success, i. e. the probability of not requiring any re-interventions, and the survival, i. e. the probability of not requiring tooth removal, of selectively versus stepwise excavated vital, non-symptomatic deciduous molars with deep lesions. In addition, we assess the restoration integrity of selectively versus stepwise excavated deciduous molars, evaluate the preference of patients, parents and dentists for one of both strategies, and comparatively assess the costs associated with each strategy.

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. Moreover, we hypothesize that patients', parents' and dentists' preference is significantly different for selective versus stepwise excavated teeth. Eventually, both initial and long-term costs of excavation methods are supposed to significantly differ.

The planned study is a secondary care-based prospective, multi-center two-arm, parallel-group, randomized controlled trial at three pediatric university dental clinics in Germany. We plan to enroll 300 patients with one or more deeply carious, sensitive and non-symptomatic deciduous molar. One molar per patient will be randomly allocated to receive one of two treatments (selective or stepwise excavation). Total follow-up time will be three years after completion of the initial treatment. Success, survival and restoration integrity will be assessed after one, two and three years. Patients', parents' and dentists' preference will be assessed after each treatment using visual-analogue scale or Likert-rating scales. Costs will be assessed for initial and follow-up treatments and will be based on a micro-costing approach.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective or Stepwise Removal of Deep Caries in Deciduous Molars: A Multi-center Randomized Controlled Trial
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Selective removal 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.

Active Comparator: Stepwise removal 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.





Primary Outcome Measures :
  1. Success (re-intervention required no/yes) [ Time Frame: 36 month ]
    The primary outcome of the study will be success (i. e. not requiring any re-intervention).


Secondary Outcome Measures :
  1. Survival (tooth removal required no/yes) [ Time Frame: 36 months ]
    Secondary outcomes will include survival (i. e. not requiring extraction).

  2. Restoration integrity (scored as alpha, beta, gamma, delta) [ Time Frame: 36 months ]
    Restoration integrity will be assessed via modified USPHS-criteria.

  3. Patients' subjective assessment of the treatment (0-10) [ Time Frame: 0 months (directly after treatment) ]
    Patients' subjective assessment of the treatment will be recorded using visual-analogue scale. For stepwise excavation, assessments will be performed twice and mean VAS-results calculated.

  4. Dentists' subjective assessment (1-6) [ Time Frame: 0 months (directly after treatment) ]
    Dentists' subjective assessment of the treatment will be reported using grades from 1 (very good) to 6 (very bad).

  5. Parents' subjective assessment (1-6) [ Time Frame: 0 months (directly after treatment) ]
    similar to dentists' assessment

  6. Treatment costs (Euro) [ Time Frame: 36 months ]
    Total treatment costs (calculated by combining costs for staff, as assessed by time required for the procedures and the number of personnel involved, and costs for transportation of patients or materials) for both initial and follow-up treatments.



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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232828


Contacts
Contact: Falk Schwendicke, OA Dr. +4930450562 ext 556 falk.schwendicke@charite.de
Contact: Sebastian Paris, Prof. Dr. +4930450562 ext 332

Locations
Germany
Ernst-Moritz-Arndt University of Greifswald, Präventive Zahnmedizin und Kinderzahnheilkunde Not yet recruiting
Greifswald, Mecklenburg Vorpommern, Germany, 17487
Contact: Christian Splieth, Prof. Dr.         
Contact: Ruth Santamaria, Dr.         
Sub-Investigator: Christian Splieth, Prof. Dr.         
Sub-Investigator: Ruth Santamaria, Dr.         
Uniklinik RWTH Aachen; Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Contact: Marina A. Petrou, Dr.         
Sub-Investigator: Marina A. Petrou, Dr.         
CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin, Abteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin Recruiting
Berlin, Germany, 14197
Contact: Christian Finke, OA Dr.    +49450562 ext 0    Christian.Finke@charite.de   
Principal Investigator: Christian Finke, OA Dr.         
CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin; Abteilungen für Zahnerhaltung und Präventive Zahnheilkunde Recruiting
Berlin, Germany, 14197
Contact: Falk Schwendicke, OA Dr.    +4930450562 ext 556    falk.schwenicke@charite.de   
Contact: Sebastian Paris, Prof. Dr.    +4930450562 ext 332    sebastian.paris@charite.de   
Principal Investigator: Falk Schwendicke, OA Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Rheinisch-Westfälische Technische Hochschule RWTH Aachen, Germany
University Medicine Greifswald
Investigators
Principal Investigator: Falk Schwendicke, OA Dr. Chatrite Berlin, Germany
Study Chair: Sebastian Paris, Prof. Dr. Charite Berlin, Germany
Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Falk Schwendicke, OA Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02232828     History of Changes
Other Study ID Numbers: CARIEX2or1
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases