Study Results
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Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2014-10-31
2018-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Selective removal
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.
Stepwise removal
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Good general health
* Minimum one active deep (D3) occlusal/occlusal-proximal, one-/two-surface caries lesion
Exclusion Criteria
* Plan to move or not resident
* Systemic disease or general disability
* Expected limited compliance
* Known allergy to study material expected exfoliation within 18 month
3 Years
9 Years
ALL
No
Sponsors
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Rheinisch-Westfälische Technische Hochschule RWTH Aachen, Germany
UNKNOWN
University Medicine Greifswald
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Falk Schwendicke
OA Dr.
Principal Investigators
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Falk Schwendicke, OA Dr.
Role: PRINCIPAL_INVESTIGATOR
Chatrite Berlin, Germany
Sebastian Paris, Prof. Dr.
Role: STUDY_CHAIR
Charite Berlin, Germany
Christian Finke, OA Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite Berlin, Germany
Marina A. Petrou, Dr.
Role: PRINCIPAL_INVESTIGATOR
Uniklinic RWTH Aachen, Germany
Christian Spleith, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Greifswald, Germany
Ruth Santamaria, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Greifswald, Germany
Locations
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Ernst-Moritz-Arndt University of Greifswald, Präventive Zahnmedizin und Kinderzahnheilkunde
Greifswald, Mecklenburg-Vorpommern, Germany
Uniklinik RWTH Aachen; Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde
Aachen, North Rhine-Westphalia, Germany
CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin, Abteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin
Berlin, State of Berlin, Germany
CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin; Abteilungen für Zahnerhaltung und Präventive Zahnheilkunde
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Sebastian Paris, Prof. Dr.
Role: CONTACT
Facility Contacts
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Christian Splieth, Prof. Dr.
Role: primary
Ruth Santamaria, Dr.
Role: backup
Marina A. Petrou, Dr.
Role: primary
References
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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.
Other Identifiers
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CARIEX2or1
Identifier Type: -
Identifier Source: org_study_id
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