- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02232828
Selective or Stepwise Removal of Deep Caries
Selective or Stepwise Removal of Deep Caries in Deciduous Molars: A Multi-center Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Falk Schwendicke, OA Dr.
- Phone Number: 556 +4930450562
- Email: falk.schwendicke@charite.de
Study Contact Backup
- Name: Sebastian Paris, Prof. Dr.
- Phone Number: 332 +4930450562
Study Locations
-
-
-
Berlin, Germany, 14197
- Recruiting
- CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin, Abteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin
-
Contact:
- Christian Finke, OA Dr.
- Phone Number: +49450562
- Email: Christian.Finke@charite.de
-
Principal Investigator:
- Christian Finke, OA Dr.
-
Berlin, Germany, 14197
- Recruiting
- CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin; Abteilungen für Zahnerhaltung und Präventive Zahnheilkunde
-
Contact:
- Falk Schwendicke, OA Dr.
- Phone Number: 556 +4930450562
- Email: falk.schwenicke@charite.de
-
Contact:
- Sebastian Paris, Prof. Dr.
- Phone Number: 332 +4930450562
- Email: sebastian.paris@charite.de
-
Principal Investigator:
- Falk Schwendicke, OA Dr.
-
-
Mecklenburg Vorpommern
-
Greifswald, Mecklenburg Vorpommern, Germany, 17487
- Not yet recruiting
- Ernst-Moritz-Arndt University of Greifswald, Präventive Zahnmedizin und Kinderzahnheilkunde
-
Contact:
- Christian Splieth, Prof. Dr.
-
Contact:
- Ruth Santamaria, Dr.
-
Sub-Investigator:
- Christian Splieth, Prof. Dr.
-
Sub-Investigator:
- Ruth Santamaria, Dr.
-
-
Nordrhein-Westfalen
-
Aachen, Nordrhein-Westfalen, Germany, 52074
- Recruiting
- Uniklinik RWTH Aachen; Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde
-
Contact:
- Marina A. Petrou, Dr.
-
Sub-Investigator:
- Marina A. Petrou, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
36 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival (tooth removal required no/yes)
Time Frame: 36 months
|
Secondary outcomes will include survival (i.
e. not requiring extraction).
|
36 months
|
Restoration integrity (scored as alpha, beta, gamma, delta)
Time Frame: 36 months
|
Restoration integrity will be assessed via modified USPHS-criteria.
|
36 months
|
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.
|
0 months (directly after treatment)
|
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).
|
0 months (directly after treatment)
|
Parents' subjective assessment (1-6)
Time Frame: 0 months (directly after treatment)
|
similar to dentists' assessment
|
0 months (directly after treatment)
|
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.
|
36 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Falk Schwendicke, OA Dr., Chatrite Berlin, Germany
- Study Chair: Sebastian Paris, Prof. Dr., Charité Berlin, Germany
- Principal Investigator: Christian Finke, OA Dr., Charité 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 and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARIEX2or1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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