Dataset Information

Selective versus stepwise removal of deep carious lesions in permanent teeth: a randomised controlled trial from Egypt-an interim analysis.

ABSTRACT:

Objectives

To 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.

Design

Randomised controlled, unicentre, clustered two-arm superiority trial.

Setting

Outpatient clinic of a private university in Cairo, Egypt.

Participants

One 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.

Interventions

Peripheral 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 measures

Primary outcome was success (absence of endodontic/restorative complications). Secondary outcomes were tooth survival and initial and total treatment costs.

Results

Zero/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).

Conclusion

Within 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 number

PACTR201603001396248.

SUBMITTER: Labib ME

PROVIDER: S-EPMC6756573 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Selective versus stepwise removal of deep carious lesions in permanent teeth: a randomised controlled trial from Egypt-an interim analysis.

Labib Mohamed E ME Hassanein Olfat E OE Moussa Makeen M Yassen Asmaa A Schwendicke Falk F

BMJ open 20190917 9

<h4>Objectives</h4>To 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.<h4>Design</h4>Randomised controlled, unicentre, clustered two-arm superiority trial.<h4>Setting</h4>Outpatient clinic of a private university in Cairo, Egypt.<h4>Participants</h4>One hundred and fifteen participants (n=132 teeth), aged 18-47 years, from Cairo, Egypt, were enrolled. Premolars/molars with occlus ...[more]

PMID: 31530615

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Project description:BackgroundDental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth.MethodThis is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes.DiscussionSCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN.Trial registration numberISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

Project description:BackgroundWhen silver diamine fluoride (SDF) is used in conjunction with conservative caries removal in deep carious lesions, the distribution depth of silver is critical for safety and effectiveness.ObjectiveThe purpose of this study is to determine the effect of selected caries removal on silver penetration when 38% SDF is applied to deep carious lesions in permanent teeth.MethodsExtracted permanent teeth with caries extending to the inner third of the dentin were used (N = 18). The periphery of the carious lesion was completely removed to the dentinoenamel junction (DEJ). In group A (n = 9), no further removal of carious tissue was performed, leaving necrotic dentin inner to the DEJ, whereas in group B (n = 9) superficial necrotic dentin was completely removed until leathery, slightly moist, reasonably soft dentin remained. SDF was applied for 3 minutes in both groups. Microcomputer tomography (micro-CT) and field emission scanning electron microscopy coupled with energy-dispersive X-ray spectroscopy (FESEM-EDS) were used to measure mineral density and silver distribution. The silver penetration depth/lesion depth (PD/LD) ratio was calculated for each sample. The Mann-Whitney U test was used to compare differences between the two groups.ResultsThe micro-CT analysis showed that the PD/LD ratios of group B (1.07-2.29) were marginally greater than those of group A (1.00-1.31). However, a statistically significant difference was not observed (pvalue = 0.5078). When stratified by remaining dentin thickness (RDT), the PD/LD ratios of group B were still greater than those of group A only when RDT was >500 µm. The FESEM-EDS analysis indicated that silver particles precipitated throughout the entire thickness of the carious lesions.ConclusionApplying SDF on a deep carious lesion and leaving the necrotic dentin pulpally did not affect silver penetration. However, the extent to which silver penetrates the remaining dentin beneath the lesions is dependent on the amount and characteristics of that dentin.

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.

Project description:ObjectivesThe aim of this randomized clinical trial was to compare selective removal to soft dentin (SRSD) and selective removal to firm dentin (SRFD) in permanent teeth. The primary outcome of the study was to compare the success rates of the two caries removal techniques. The secondary outcome of the study was to investigate whether or not calcium silicate-based material (CS) had an effect on the success rate of the treatment.Materials and methodsBetween November 2018 and March 2020, patients with deep caries lesions were invited to participate in the study. Posterior teeth (N = 165) with primary caries lesion radiographically extending ¾ of dentin and positive response to cold test were randomly selected. A total of 134 participants meeting the inclusion criteria were randomized to SRSD and SRFD (control) groups. After the caries removal procedure, teeth with exposed pulps were assigned to the pulp exposure (PE) group, and the SRSD group was further divided into test 1 (with CS) and test 2 groups (without CS). Success was defined as a positive response to the cold test, a negative response to percussion, the absence of pain, an abscess, a fistula, and periapical alterations. Fisher-Freeman-Halton exact tests, Kaplan-Meier survival analysis, and the log-rank tests were performed for comparisons between groups.ResultsNo statistically significant difference was found between the success rates of test 1 (100%) and test 2 (93.5%) groups, whereas the proportion of success in control (82.4%) and PE (84%) groups were significantly lower when compared with test groups (p = 0.024; p < 0.05) at the end of 2-year follow-up.ConclusionsSRSD had a higher success rate when compared to SRFD to treat deep carious lesions after 2 years of follow-up. The use of CS material after SRSD as a liner had no effect on the treatment outcome.Clinical relevanceSRSD with good coronal sealing might be recommended without CS application for the treatment of deep caries lesions in permanent teeth.Trial registrationClinical trial registration number NCT04052685 (08/09/2019).

Project description:BackgroundThe lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry.MethodsOverall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C?+?P), biological management of carious lesions and prevention (B?+?P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis.ResultsParticipants discussed perceived effectiveness of, and familiarity with, the three techniques. The C?+?P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B?+?P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children.ConclusionsRCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials.

Project description:PurposeThis umbrella review systematically appraised published systematic reviews on Minimal Intervention Dentistry interventions carried out to manage dentine carious primary teeth to determine how best to translate the available evidence into practice, and to provide recommendations for what requires further research.MethodAn experienced information specialist searched MEDLINE, Embase, Cochrane Database of Systematic Reviews, Epistemonikos, Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, and the NIHR Journals Library. In addition, the PROSPERO database was searched to identify forthcoming systematic reviews. Searches were built around the following four concepts: primary teeth AND caries/carious lesion AND Minimal Intervention Dentistry AND systematic review/meta-analysis. Searches were restricted to English language, systematic reviews with/without meta-analyses published between January 2000 and August 2020. Two reviewers independently screened all titles and abstracts. Interventions included involved no dentine carious tissue removal (fissure sealants, resin infiltration, topical application of 38% Silver Diamine Fluoride, and Hall Technique), non-restorative caries control, and selective removal of carious tissue involving both stepwise excavation and atraumatic restorative treatment. Systematic reviews were selected, data extracted, and risk of bias assessed using ROBIS by two independent reviewers. Studies overlap was calculated using corrected covered area.ResultsEighteen systematic reviews were included in total; 8 assessed the caries arresting effects of 38% Silver Demine Fluoride (SDF), 1 on the Hall Technique (HT), 1 on selective removal of carious tissue, and eight investigated interventions using atraumatic restorative treatment (ART). Included systematic reviews were published between 2006 and 2020, covering a defined time frame of included randomised controlled trials ranging from 1969 to 2018. Systematic reviews assessed the sealing efficacy of fissure sealants and resin infiltration in carious primary teeth were excluded due to pooled data reporting on caries arrest in both enamel and outer third of dentine with the majority of these carious lesions being limited to enamel. Therefore, fissure sealants and resin infiltration are not recommended for the management of dentinal caries lesions in primary teeth. Topical application of 38% SDF showed a significant caries arrest effect in primary teeth (p < 0.05), and its success rate in arresting dental caries increased when it was applied twice (range between 53 and 91%) rather than once a year (range between 31 and 79%). Data on HT were limited and revealed that preformed metal crowns placed using the HT were likely to reduce discomfort at time of treatment, the risk of major failure (pulp treatment or extraction needed) and pain compared to conventional restorations. Selective removal of carious tissue particularly in deep carious lesions has significantly reduced the risk of pulp exposure (77% and 69% risk reduction with one-step selective caries removal and stepwise excavation, respectively). ART showed higher success rate when placed in single surface compared to multi-surface cavities (86% and 48.7-88%, respectively, over 3 years follow-up).ConclusionMinimal Intervention Dentistry techniques, namely 38% SDF, HT, selective removal of carious tissue, and ART for single surface cavity, appear to be effective in arresting the progress of dentinal caries in primary teeth when compared to no treatment, or conventional restorations. There is clear need to increase the emphasis on considering these techniques for managing carious primary teeth as a mainstream option rather than a compromise option in circumstances where the conventional approach is not possible due to cooperation or cost.

Dataset Information

Selective versus stepwise removal of deep carious lesions in permanent teeth: a randomised controlled trial from Egypt-an interim analysis.

Objectives

Design

Setting

Participants

Interventions

Primary and secondary outcome measures

Results

Conclusion

Trial registration number

Publications

Selective versus stepwise removal of deep carious lesions in permanent teeth: a randomised controlled trial from Egypt-an interim analysis.

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