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Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results.

ABSTRACT: BACKGROUND:the aim of this study was to assess the 2-year pulp survival of deep carious lesions in teeth excavated using a self-limiting protocol in a single-blind randomized controlled clinical trial. METHODS:At baseline, 101 teeth with deep carious lesions in 86 patients were excavated randomly using self-limiting or control protocols. Standardized clinical examination and periapical radiographs of teeth were performed after 1- and 2-year follow-ups (REC 14/LO/0880). RESULTS:During the 2-year period of the study, 24 teeth failed (16 and 8 at T12 and T24, respectively). Final analysis shows that 39/63 (61.9%) of teeth were deemed successful (16/33 (48.4%) and 23/30 (76.6%) in the control and experimental groups, respectively with a statistically significant difference (z score = 2.3, p = 0.021). Of teeth with severe and mild symptoms at T0, 42.9% and 36.7% respectively failed at T24 (p > 0.05). Within the self-limiting group, there was a lower success in premolars compared to molars (p < 0.05). CONCLUSION:after 2 years, there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis. Molars showed higher success than premolars in teeth excavated using the self-limiting protocol. There was no statistically significant association between the outcome and the severity of symptoms at T0 (ClinicalTrials.gov NCT03071588).

SUBMITTER: Ali AH

PROVIDER: S-EPMC7564758 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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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.

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Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results.

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