Clinical trial NCT02232828: Selective or Stepwise Removal of Deep Caries
Official title: Selective or Stepwise Removal of Deep Caries in Deciduous Molars: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Rheinisch-Westfälische Technische Hochschule RWTH Aachen, Germany
name: University Medicine Greifswald
First posted: 2014-09-05
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Success (re-intervention required no/yes)
timeFrame: 36 month
Secondary outcomes:
measure: Survival (tooth removal required no/yes)
timeFrame: 36 months
measure: Restoration integrity (scored as alpha, beta, gamma, delta)
timeFrame: 36 months
measure: Patients' subjective assessment of the treatment (0-10)
timeFrame: 0 months (directly after treatment)
measure: Dentists' subjective assessment (1-6)
timeFrame: 0 months (directly after treatment)
measure: Parents' subjective assessment (1-6)
timeFrame: 0 months (directly after treatment)
measure: Treatment costs (Euro)
timeFrame: 36 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt University of Greifswald, Präventive Zahnmedizin und Kinderzahnheilkunde
state: Mecklenburg Vorpommern
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen; Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin, Abteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin
city: Berlin
country: Germany
facility: CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin; Abteilungen für Zahnerhaltung und Präventive Zahnheilkunde
Study officials:
affiliation: Chatrite Berlin, Germany
name: Falk Schwendicke, OA Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite Berlin, Germany
name: Sebastian Paris, Prof. Dr.
role: STUDY_CHAIR
affiliation: Charite Berlin, Germany
name: Christian Finke, OA Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniklinic RWTH Aachen, Germany
name: Marina A. Petrou, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Greifswald, Germany
name: Christian Spleith, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Greifswald, Germany
name: Ruth Santamaria, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.