Dataset Information

Pulp liner materials in selective caries removal: study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

The literature shows that selective carious tissue removal (SCTR) decreases the number and diversity of bacteria, stops the caries process and reduces the risk of pulp exposure. However, no consensus exists on which pulp liner would be suitable for teeth undergoing SCTR. So, this study will verify the in vivo response of dentine-pulp complex after SCTR in primary teeth with or without pulp liner material.

Methods and analysis

A randomised clinical trial, double-blinded, parallel-group and allocation concealment will be conducted with the enrolment of 384 patients from 5 to 9 years, with one maxillary/mandibular first/second primary molars with deep occlusal/occlusoproximal cavities. The remaining dentine will be lined with calcium hydroxide cement-group 1; mineral trioxide aggregate-group 2 and without liner-group 3. The primary outcome will be success of the of dentine-pulp complex evaluated clinically and radiographically at 6, 12 and 24 months, while the secondary outcomes will be the measurement of the dentine barrier on periapical radiographs. During all study, two trained and calibrated examiners will evaluate the treated teeth clinically and radiographically. Interexaminer and intraexaminer reliability will be verified by casual and systematic error. The Kolmogorov-Smirnov test will be adopted to test the normality of continuous variables. Comparisons among groups will be performed by using the ?² test and anaylsis of variance, followed by Tukey test (p<0.05). The logistic regression will be applied, and the degrees of this association will be measured using the OR and 95% CI.

Ethics and dissemination

The present protocol was submitted and approved by the Ethical Committee of the University of São Paulo, Bauru, São Paulo, Brazil (CAAE: 79123517.0.0000.5417). Consent for publication will be obtained from all parents or legal guardians. Results of this study will be reported in full through peer-reviewed journals.

Trial registration number

RBR-9fsxnn.

SUBMITTER: Stafuzza TC

PROVIDER: S-EPMC7798680 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Pulp liner materials in selective caries removal: study protocol for a randomised controlled trial.

Stafuzza Tássia Carina TC Vitor Luciana Lourenço Ribeiro LLR Lourenço Neto Natalino N Rios Daniela D Cruvinel Thiago T Sakai Vivien Thiemy VT Moretti Ana Beatriz Silveira ABS Machado Maria Aparecida Andrade Moreira MAAM Oliveira Thais Marchini TM

BMJ open 20210108 1

<h4>Introduction</h4>The literature shows that selective carious tissue removal (SCTR) decreases the number and diversity of bacteria, stops the caries process and reduces the risk of pulp exposure. However, no consensus exists on which pulp liner would be suitable for teeth undergoing SCTR. So, this study will verify the in vivo response of dentine-pulp complex after SCTR in primary teeth with or without pulp liner material.<h4>Methods and analysis</h4>A randomised clinical trial, double-blinde ...[more]

PMID: 33419899

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Project description:BackgroundFor treating deep caries lesions, selective or stepwise (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 retreatments, 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 retreatments have been reported yet.Methods/designThe planned study is a prospective multicenter, two-arm parallel group, randomized controlled clinical trial comparing selective and stepwise excavation in deciduous molars with deep, active caries lesions without pulpal symptoms. We will recruit 300 children aged between three and nine-years-old with a minimum of one such molar. Patients participating in another study, or those with systemic diseases, disabilities or known allergies to used materials as well patients with teeth expected to exfoliate within the next 18 months will be excluded. After inclusion, sequence generation will be performed. Initial treatment will follow dental routine. During excavation, leathery, moist and reasonably soft dentin will be left in proximity to the pulp followed by adhesive restoration of the cavity. Afterwards, patients', dentists' and parents' subjective assessment of the treatment will be recorded using visual analogue or Likert scales. Re-examination will be performed after six months, and only then teeth will be allocated to one of the two interventions. Selectively excavated teeth will not be treated further, whilst for stepwise caries removal, a second excavation will be performed until only hard dentin remains. Clinical re-evaluations will be performed after 12, 24 and 36 months. Restorations will be reassessed using modified Ryge criteria. Objectively or subjectively required retreatments will determine success and survival. Retreatments will be evaluated both subjectively and regarding generated costs.DiscussionBased on the results of the trial, decision-making for treating deep caries lesions in deciduous molars based on multiple criteria should be feasible.Trial registrationClinicaltrials.gov identifier: NCT02232828 (registered on 29 November 2014).

Project description:IntroductionPrimary goal of restorative caries therapy is to preserve pulp vitality and the dentition. Whereas the conventional approach of complete caries removal aims at the elimination of all affected substances without regard to losses of hard tissue or pulp vitality, the innovative concept of selective caries removal (SCR) is characterised by a targeted and non-invasive excavation. It presents a lower risk of accidental pulp exposure, which reportedly has a positive effect on tooth survival. Although clinical data show the benefits of SCR, knowledge about the biological processes during this procedure in the pulp-dentine complex of permanent teeth is scarce. Hence, the aim of this work is to systematically scope the existing literature and map the existing evidence according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guideline. This protocol details the scoping review's methodological and analytical approaches.Methods and analysisFirst, a structure was established (phase I) as basis for a systematic scoping of literature (phase II). In the course of phase I, a total of 100 systematic reviews related to selective caries removal were searched in MEDLINE and information or theories on the biological processes were extracted. During the entire procedure, two reviewers independently screened the articles, and controversies were mediated by vote of a third reviewer. Eventually, it became apparent that different biological explanations can be organised into four categories: pulp response, cavity seal, remaining bacteria and cavity liner. Based on this structure, a search for original publications (phase II) will be performed and retrieved evidence will be assembled using a predefined conceptual framework.Ethics and disseminationAs primary data will not be included in this study, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries for key stakeholders.

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: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:BackgroundIn people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface between residual limb and prosthetic socket, where the objectives of sufficient weight distribution and suspension are conflicting with the necessity to facilitate heat exchange and limit contact pressure and friction. Recently, prosthesis liners that contain phase-change material have become commercially available, holding the promise that the micro climate at the interface between the residual limb skin and the prosthetic socket can be regulated to reduce the users' tendency to sweat. Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners. However, the clinical relevance of those findings remains unclear. The purpose of this study is to investigate whether longer (6+ months) periods of use of phase-change material based temperature-control liners have clinically meaningful effects.MethodsThe protocol is a double-blind longitudinal cross-over research design. A sample of trans-tibial prosthesis users are wearing their regular gel or silicone liners for six months and phase-change material liners for another six months in a randomized sequence. Their prostheses is equipped with activity monitors to detect days when they could not wear their prosthesis. In six-week intervals, individuals' activity, physical performance, and overall prosthesis assessment is recorded using standardized methods.DiscussionExpected results will inform prescription and reimbursement practice of phase-change material-based prosthesis liners and will help improve and economize prosthetic fitting for people with limb loss. The design and duration of the protocol, including randomization, blinding, and within-subject comparison, will generate scientific evidence of a comparably high level. Inclusion of a comparably large sample and different climates, e.g. across all four seasons, will make findings applicable to a large number of prosthesis users.Trial registrationClinicaltrials.gov, NCT03428815. Registered on 12 February 2018.

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:BackgroundA three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C?+?P), Biological with best practice prevention (B?+?P), or best practice Prevention Alone (PA).MethodsData on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%.ResultsA total of 1144 children were randomised with data on 1058 children (C?+?P n?=?352, B?+?P n?=?352, PA n?=?354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36?months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B?+?P. In terms of effectiveness, on average, there were fewer incidences of, (-?0.06; 97.5% CI: -?0.14 to 0.02) and fewer episodes of dental pain and/or infection (-?0.14; 97.5% CI: -?0.29 to 0.71) in B?+?P compared to PA. C?+?P was unlikely to be considered cost-effective, as it was more costly and less effective than B?+?P.ConclusionsThe mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B?+?P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B?+?P being considered cost-effective never exceeded 75%.Trial registrationThe trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

Dataset Information

Pulp liner materials in selective caries removal: study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Pulp liner materials in selective caries removal: study protocol for a randomised controlled trial.

Similar Datasets

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