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Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.

ABSTRACT: We aimed to compare subjective (S) vs. objective (O) selective carious tissue removal using hand-excavation versus a self-limiting polymer bur, respectively. A community-based single-blind cluster-randomized controlled superiority trial was performed. This is a 1-year-interim analysis. 115 children (age 7-8 years) with ?1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60?S/55?O). The cluster was the child, with eligible molars being treated identically (91?S/86?O). Cavities were prepared and carious tissue on pulpo-proximal walls selectively removed using hand instruments (S), or a self-limiting polymer bur (Polybur P1, Komet). Cavities were restored using glass-hybrid material (Equia Forte, GC). Treatment times and children's satisfaction were recorded. Generalized-linear models (GLM) and multi-level Cox-regression analysis were applied. Initial treatment times were not significantly different between protocols (mean; 95%CI S: 433; 404-462?sec; O: 412; 382-441?sec; p?=?0.378/GLM). There was no significant difference in patients' satisfaction (p?=?0.164). No pulpal exposures occurred. 113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%). Pulpal complications occurred in 5(6%) O and 2(2.2%) S molars, respectively. Risk of failure was not significantly associated with the removal protocol, age, sex, dental arch or tooth type (p?>?0.05/Cox), but was nearly 5-times higher in multi-surface than single-surface restorations (HR: 4.60; 95% CI: 1.70-12.4). Within the limitations of this interim analysis, there was no significant difference in treatment time, satisfaction and risk of failure between O and S.

SUBMITTER: Marques MG

PROVIDER: S-EPMC7272648 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.

Marques Marta Gomes MG Hilgert Leandro Augusto LA Silva Larissa Ribeiro LR Demarchi Karine Medeiros KM Dos Santos Matias Patrícia Magno PM Ribeiro Ana Paula Dias APD Leal Soraya Coelho SC Paris Sebastian S Schwendicke Falk F

Scientific reports 20200604 1

We aimed to compare subjective (S) vs. objective (O) selective carious tissue removal using hand-excavation versus a self-limiting polymer bur, respectively. A community-based single-blind cluster-randomized controlled superiority trial was performed. This is a 1-year-interim analysis. 115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60 S/55 O). The cluster was the child, with eligible molars being treated identically (91 S/86 ...[more]

PMID: 32499552

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Project description:INTRODUCTION:Selective (incomplete/partial) carious tissue removal is suitable for treating deep carious lesions in teeth with vital, asymptomatic pulps. In the periphery of a cavity, removal to hard dentin is performed, while in pulpo-proximal areas, leathery or soft dentin is left to avoid pulp exposure. As the decision of what contains 'soft' or 'leathery' dentin is subjective, using self-limiting burs which help to standardise the hardness of the remaining dentin, has been suggested to increase the reliability of carious tissue removal. The trial compares subjectively measured selective carious tissue removal in deep lesions in primary teeth with objectively measured selective removal with a self-limiting bur (Polybur, Komet). METHODS AND ANALYSIS:A community-based single-blind clustered randomised controlled superiority trial nested into a larger evaluation is performed. Recruitment for this trial has been concluded. We have recruited 115 children aged 6-8 years with ?1?vital primary molar with a deep dentin lesion. The unit of randomisation was the child, with all eligible molars per child treated identically. Treatment was performed in a mobile dental unit. Subjective and objective carious tissue removal was performed at random. Teeth were restored using glass ionomer cement (Equia Forte, GC). Our primary outcome will be the time until complications occur, evaluated via multilevel survival analysis. Secondary outcomes will be the time until extraction is needed, subjective satisfaction of the child with the treatment (measured using a Likert scale) and cost-effectiveness. Re-examination will be performed after 12, 24 and 36 months (the final examination is expected in 2020). ETHICS AND DISSEMINATION:This trial has been approved by the Ethics Committee of the Health Sciences of the University of Brasília (CAAE 51310415.0.0000.0030). Trial results will be published in peer-reviewed journals and presented on conferences. TRIAL REGISTRATION NUMBER:NCT02754466.

Project description:ObjectivesTo compare the success, survival and costs of selective versus stepwise carious tissue removal (SE/SW) in permanent teeth with deep (>2/3 dentine depth) carious lesions.DesignRandomised controlled, unicentre, clustered two-arm superiority trial.SettingOutpatient clinic of a private university in Cairo, Egypt.ParticipantsOne hundred and fifteen participants (n=132 teeth), aged 18-47 years, from Cairo, Egypt, were enrolled. Premolars/molars with occlusal/occlusal-proximal deep lesions (radiographically >2/3 dentine), sensible pulps, without spontaneous pain, were included.InterventionsPeripheral carious tissue removal to hard dentine was performed. Pulpo-proximally, soft dentine was left. A glass ionomer (GI) restoration was placed. After 3-4 months, teeth were randomly allocated to SE (n=66), with reduction of the GI into a base and no further tissue removal, followed by a composite resin restoration, or SW (n=66), with full removal of the GI, additional excavation until firm dentine pulpo-proximally, followed by a GI-based composite restoration. Mean follow-up was 1 year.Primary and secondary outcome measuresPrimary outcome was success (absence of endodontic/restorative complications). Secondary outcomes were tooth survival and initial and total treatment costs.ResultsZero/five pulp exposures occurred during SE/SW, and seven/five SE/SW teeth required endodontic therapy. Success after 12 months was 89.4% for SE and 84.9% for SW. The estimated mean time free of complications was 23 and 18 months for SE and SW, respectively, without significant differences between SE and SW (p>0.05/Cox). Initial treatment costs were significantly higher for SW (mean (SD): 507.5 (123.4) Egyptian pounds (EGP)) than SE (mean (SD): 456.6 (98.3) EGP), while total costs showed no significant difference (p>0.05).ConclusionWithin the limitations of this interim analysis, and considering the depth of these lesions (>2/3 dentine), SE and SW showed similar risk of failure and overall costs after 1 year.Trial registration numberPACTR201603001396248.

Project description:ObjectivesFor well-defined deep (>?2/3 dentin extension) carious lesions, selective (SE) or stepwise (SW) carious tissue removals have been recommended, while there is limited comparative evidence for both. We compared SE and SW over 24 months in a randomized controlled trial.MethodsA two-arm superiority trial was conducted comparing SW/SE in primary molars without pulpal symptoms but well-defined deep lesions. Seventy-four children (1 molar/child) aged 3-9 years were recruited. In a first step, peripheral carious tissue was removed until hard dentin remained, while in proximity to the pulp, leathery dentin was left. An adhesive compomer restoration was placed and restorations re-examined after 6 months. In SW, re-entry and removal to firm dentin was conducted pulpo-proximally, followed by re-restoration. Molars were re-evaluated for a total of 24 months. Our primary outcome was success (absence of restorative/endodontic complications or pulp exposures). Secondary outcomes included total treatment and opportunity costs and restoration quality, assessed using modified USPHS criteria.ResultsAfter 24 months, 63 molars (31 SE, 32 SW) were re-assessed. Four failures occurred (2 exposures in SW; 2 pulpal complications in SE, 1 of them leading to extraction, p?>?0.05). Restoration integrity was satisfying in both groups (USPHS A/B/C in 21/8/0 SE and 23/7/0 SW, p?>?0.05). Treatment and opportunity costs were significantly higher in SW than SE (mean 171?±?51 vs. 106?±?90; p?<?0.001).ConclusionsAfter 2 years, SE and SW showed similar efficacy for managing deep carious lesions in primary molars. The higher costs for SW should be considered during decision-making.Clinical significanceIn primary molars with well-defined deep carious lesions SE was less costly and similarly efficacious like SW. From a cost and applicability perspective, SW may need to be indicated restrictively, e.g., for very deep (>?3/4 dentin extension) lesions only.Trial registrationClinicalTrials.gov Identifier: NCT02232828.

Dataset Information

Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.

Publications

Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.

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