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.

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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.

Similar Datasets

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