Cost-effectiveness of restorative treatments for permanent molars with severe molar incisor hypomineralization: perspectives for the Brazilian public health system.

OBJECTIVES: To undertake a cost-effectiveness analysis of restorative treatments for a first permanent molar with severe molar incisor hypomineralization from the perspective of the Brazilian public system. MATERIALS AND METHODS: Two models were constructed: a one-year decision tree and a ten-year Markov model, each based on a hypothetical cohort of one thousand individuals through Monte Carlo simulation. Eight restorative strategies were evaluated: high viscosity glass ionomer cement (HVGIC); encapsulated GIC; etch and rinse adhesive + composite; self-etch adhesive + composite; preformed stainless steel crown; HVGIC + etch and rinse adhesive + composite; HVGIC + self-etch adhesive + composite, and encapsulated GIC + etch and rinse adhesive + composite. Effectiveness data were sourced from the literature. Micro-costing was applied using 2022 USD market averages with a 5% variation. Incremental cost-effectiveness ratio (ICER), net monetary benefit (%NMB), and the budgetary impact were obtained. RESULTS: Cost-effective treatments included HVGIC (%NMB = 0%/ 0%), encapsulated GIC (%NMB = 19.4%/ 19.7%), and encapsulated GIC + etch and rinse adhesive + composite (%NMB = 23.4%/ 24.5%) at 1 year and 10 years, respectively. The benefit gain of encapsulated GIC + etch and rinse adhesive + composite in relation to encapsulated GIC was small when compared to the cost increase at 1 year (gain of 3.28% and increase of USD 24.26) and 10 years (gain of 4% and increase of USD 15.54). CONCLUSION: Within the horizon and perspective analyzed, the most cost-effective treatment was encapsulated GIC restoration. CLINICAL RELEVANCE: This study can provide information for decision-making.

2-year survival and cost analysis of occlusoproximal ART restorations using encapsulated glass ionomer cement in primary molars: a randomized controlled trial.

BACKGROUND: The survival of ART restorations can be influenced by the choice of the restorative material. The aim of this randomized non-inferiority controlled trial was to compare the 2-year survival rate and cost analysis of two encapsulated glass ionomer cements (GIC) as occlusoproximal restorative materials in primary molars. METHODS: Children from public schools in Tietê (Brazil), aged 4-8 years with occlusoproximal dentine carious lesions in primary molars were selected and randomly assigned to receive either Equia Forte (EF) or Riva Self Cure (RSC) as restorative materials. Treatment was carried out by two trained final-year dental students in schools following ART premises. Restorations were assessed by a trained and calibrated examiner after 2, 6, 12, 18, and 24 months. The primary outcome was restoration survival after 2 years, analyzed using Kaplan-Meier survival and Cox regression analysis (α = 5%). Professional and materials costs for each group were collected in Brazilian Reais (R$) and converted into US dollars (US$) and analyzed using Monte-Carlo simulation. RESULTS: A total of 152 children (76 per group) were included in the study, and 121 (79%) were evaluated after 2 years. The overall 2-year restoration survival rate was 39% (EF = 45%; RSC = 32%) with no difference between the groups. The baseline and 2-year total cost of restorations using RSC was lower when compared to EF (incremental cost: US$ 6.18). CONCLUSION: After two years of follow-up, Riva Self Cure shows comparable restoration survival rates to Equia Forte, being more cost-effective in the Brazilian perspective. TRIAL REGISTRATION: This randomized clinical trial was registered on ClinicalTrials.Gov - NCT02730000.

Cost-effectiveness and Acceptance in Children and Parents of the Hall Technique: Systematic Review of Clinical Trials.

AIMS: The purpose of this systematic review was to evaluate the cost-effectiveness and acceptance of children and their parents of the Hall technique (HT) for dental rehabilitation in pediatric dentistry. BACKGROUND: The approach of the HT is that of minimally invasive treatment of the dental element and is used exclusively on primary molars. Various studies in the literature point to HT as a restorative option well accepted by children and parents and quite predictable, with low retreatment rates and good cost-effectiveness for the management of primary molars with carious lesions. However, no systematic review in the literature has approached randomized clinical trials on these topics to produce a high level of evidence and help establish clinical HT protocols. REVIEW RESULTS: Eight articles were selected for the systematic review. The HT was more cost-effective than procedures using other restorative materials. Regarding acceptance, in terms of esthetics, high percentages of satisfaction were reported for parents and children, with a divergence between studies in the comparison of esthetic preference with atraumatic restorative treatment. However, when considering crown cementation pain, comfort, anxiety, preference, and satisfaction, the HT was generally better evaluated when compared to other restorative materials. CONCLUSION: The HT is an excellent restorative option when considering cost-effectiveness and acceptance and is recommended for use in daily clinical practice. CLINICAL SIGNIFICANCE: Results indicate that HT is superior to other restorative materials regarding its acceptance by children and parents in terms of pain, comfort, anxiety, and crown preference and satisfaction. There were also high percentages of satisfaction with esthetics. Hall technique may initially appear expensive for dentists, but its effectiveness over time and the lesser need for consultations and reinventions ensure better cost-benefit than other restorative materials. How to cite this article: Valentim FB, Moreira KMS, Carneiro VC, et al. Cost-effectiveness and Acceptance in Children and Parents of the Hall Technique: Systematic Review of Clinical Trials. J Contemp Dent Pract 2023;24(12):1016-1025.

Demographic factors in the choice of coronal restoration after root canal treatment in the Swedish adult population.

BACKGROUND: After root canal treatment, a choice is made between different coronal restorations which in the long run could affect the survival of the tooth. OBJECTIVE: To compare demographic characteristics between individuals choosing an indirect coronal restoration (crown, inlay/onlay) and individuals choosing other restorations after completion of a root filling. METHODS: The cohort consisted of all root-filled upper first molars that were reported to the tax-funded Swedish Social Insurance Agency (SSIA) during 2009. After registration of the root filling, any subsequent coronal restorations within 2 years were identified. The crown group consisted of individuals registered with an indirect coronal restoration and the restoration group was the remaining individuals with a direct coronal restoration or lacking registration. Demographic data (gender, disposable income, age, educational level, civil status and country of birth) were received from Statistics Sweden or the SSIA. Statistical analyses included chi-square test, t test and logistic regression analysis. P < 0.05 was considered statistically significant. RESULTS: An indirect coronal restoration was received by 7806 individuals (21.9%), and 27 886 individuals (78.1%) received a direct restoration. All demographic variables except gender differed significantly between groups. Logistic regression analysis found significant associations for all demographic variables and the registration of an indirect restoration except for country of birth and gender. CONCLUSIONS: The identified demographic differences between individuals choosing to restore their newly root-filled teeth with an indirect restoration compared to those receiving other restorations may indicate that the tax-funded Swedish dental insurance fails to provide dental care on equal terms for Swedish citizens.

The cost-utility of school-based first permanent molar sealants programs: a Markov model.

BACKGROUND: Evidence of the cost-effectiveness of school-based first permanent molar sealants programs is not yet fully conclusive. The aim of this study was to determine the incremental cost-utility ratio (ICUR) of school-based prevention programs for the application of sealants in molars of schoolchildren compared with non-intervention. METHODS: A cost-utility analysis based on a Markov model was carried out using probability distribution. The utility was measured in quality-adjusted tooth years (QATY). The assessment was carried out from the public payer's perspective with a six-year time horizon. Costs and benefits were discounted at 3% per year. Only direct costs were evaluated, expressed in Chilean pesos (CLP) at 7th May at 2019 values (exchange rate USD = CLP 681.09). Univariate deterministic sensitivity analysis and probabilistic analysis were carried out. RESULTS: After a six-year follow up, the cost of sealing all first permanent molars was found to be higher than non-intervention, with a mean cost difference of USD 1.28 (CLP 875) per molar treated. The "seal all" strategy was more effective than non-intervention, generating 0.2 quality-adjusted tooth years more than non-intervention. The ICUR of the "seal all" strategy compared to non-intervention was USD 6.48 (CLP 4,412) per quality-adjusted tooth years. The sensitivity analysis showed that the increase in caries was the variable which most influenced the ICUR. CONCLUSIONS: A school-based sealant program is a cost-effective measure in populations with a high prevalence of caries.

Comparative analysis of general dental practitioners' fees and scheduled fees for root canal treatment and coronal restorations in the adult population of Sweden: a 5-year follow-up of data from the Swedish Dental Register.

AIM: To investigate the fees charged by Swedish dentists for root fillings, coronal restorations and further dental interventions during a follow-up period of 5-6 years. METHODOLOGY: A total of 248 299 root fillings were linked with the tooth, the patient and the provider and entered into the Swedish Social Insurance Agency register in 2009. The data register also recorded the subsidy-based (scheduled) fee and the fee actually charged for the root fillings. Fees charged for direct or indirect coronal restorations and additional interventions during the follow-up period were also recorded. One-way anova and t-test were used for statistical analysis. RESULTS: The mean overall fee charged for a root filling was approximately 332 Euro and differed only marginally (13 Euro) from the scheduled fee. The total mean fee for preservation of a root filled tooth was 717 Euro, which included the root canal treatment, the coronal restoration and any additional interventions during the follow-up period. The fees for indirectly restored root filled teeth were significantly higher (1105 Euro) than for directly restored teeth (610 Euro), despite further additional treatment (P < 0.001). The mean fee for teeth which were subsequently extracted was higher (769 Euro) than for the retained teeth (711 Euro) (P < 0.001). CONCLUSIONS: Fees charged by Swedish dentists for root canal treatment were in accordance with the scheduled fees. The overall mean fee was significantly higher for root filled teeth with indirect restorations than for teeth with direct coronal restorations. However, prospective clinical cost-effectiveness studies are needed to analyse the total costs.

Consequences of community water fluoridation cessation for Medicaid-eligible children and adolescents in Juneau, Alaska.

BACKGROUND: The general aim of this research was to determine whether cessation of community water fluoridation (CWF) increased oral health disparities, as measured by dental caries procedures and restoration costs for children and adolescents. METHODS: The analysis was based on all Medicaid dental claims records of 0- to 18-year-old patients residing in zip code 99801 (Juneau, Alaska) during an optimal CWF year (2003, n = 853) compared to all claims for the same age group from 2012 (n = 1052), five years after cessation of CWF. A bivariate analysis (Mann-Whitney U test) of the mean number of caries procedures performed per client was conducted in the study groups under both independent CWF conditions. Furthermore, logistic regression was performed using the dependent variables of caries procedures and the cost of caries-related procedures, with adjustments for CWF group, gender, and race. RESULTS: The statistically significant results included a higher mean number of caries-related procedures among 0- to 18-year-old and < 7-year-old patients in the suboptimal CWF group (2.35 vs. 2.02, p < 0.001; 2.68 vs. 2.01, p = 0.004, respectively). The mean caries-related treatment costs per patient were also significantly higher for all age groups, ranging from a 28 to 111% increase among the suboptimal CWF cohorts after adjusting for inflation. The binary logistic regression analysis results indicated a protective effect of optimal CWF for the 0- to 18-year-old and < 7-year-old age groups (OR = 0.748, 95% CI [0.62, 0.90], p = 0.002; OR = 0.699, 95% CI [0.52, 0.95], p = 0.02, respectively). Additionally, the age group that underwent the most dental caries procedures and incurred the highest caries treatment costs on average were those born after CWF cessation. CONCLUSIONS: These results expand our understanding of caries epidemiology under CWF cessation conditions and reaffirm that optimal CWF exposure prevents dental decay. These findings can offer fiscal estimates of the cost burden associated with CWF cessation policies and help decision-makers advance oral health, prevent dental caries, and promote equity in oral health outcomes.

Utilization of tooth filling services by people with disabilities in Taiwan.

BACKGROUND: The oral condition of people with disabilities has considerable influence on their physical and mental health. However, nationwide surveys regarding this group have not been conducted. For this study, we used the National Health Insurance Research Database to explore the tooth filling utilization among people with disabilities. METHODS: Using the database of the Ministry of the Interior in 2008 which included people with disabilities registered, we merged with the medical claims database in 2008 of the Bureau of National Health Insurance to calculate the tooth filling utilization and to analyze relative factors. We recruited 993,487 people with disabilities as the research sample. RESULTS: The tooth filling utilization was 17.53 %. The multiple logistic regression result showed that the utilization rate of men was lower than that of women (OR = 0.78, 95 % CI = 0.77-0.79) and older people had lower utilization rates (aged over 75, OR = 0.22, 95 % CI = 0.22-0.23) compared to those under the age of 20. Other factors that significantly influenced the low tooth filling utilization included a low education level, living in less urbanized areas, low economic capacity, dementia, and severe disability. CONCLUSION: We identified the factors that influence and decrease the tooth-filling service utilization rate: male sex, old age, low education level, being married, indigenous ethnicity, residing in a low urbanization area, low income, chronic circulatory system diseases, dementia, and severe disabilities. We suggest establishing proper medical care environments for high-risk groups to maintain their quality of life.

Caries and costs: an evaluation of a school-based fluoride varnish programme for adolescents in a Swedish region.

UNLABELLED: In 2003, 19 public dental clinics in Västra Götaland Region implemented a population-based programme with fluoride varnish applications at school every six months, for all 12 to 15 year olds. In 2008, the programme was extended to include all 112 clinics in the region. OBJECTIVE: To evaluate caries increment and to perform a cost analysis of the programme. BASIC RESEARCH DESIGN: A retrospective design with caries data for two birth cohorts extracted from dental records. Three groups of adolescents were compared. For Group 1 (n = 3,132), born in 1993, the fluoride varnish programme started in 2003 and Group 2 (n = 13,490), also born in 1993, had no fluoride varnish programme at school. These groups were compared with Group 3 (n = 11,321), born in 1998, when the programme was implemented for all individuals. The total cost of the four-year programme was estimated at 400SEK (≈ 44€) per adolescent. RESULTS: Caries prevalence and caries increment in 15 year olds were significantly lower after the implementation of the programme. Group 2, without a programme, had the highest caries increment. The cost analysis showed that it was a break-even between costs and gains due to prevented fillings at the age of 15. CONCLUSIONS: This school-based fluoride varnish programme, implemented on a broad scale for all 12 to 15 year olds, contributed to a low caries increment at a low cost for the adolescents in the Västra Götaland Region in Sweden.

Factors affecting direction and strength of patient preferences for treatment of molar teeth with nonvital pulps.

AIM: To elicit the factors affecting willingness to pay (WTP) values for the preferred options of participants for dealing with a molar tooth with a nonvital pulp, a common but difficult problem. METHODOLOGY: A total of 503 patients were recruited from dental practices in the North East of England and interviewed. Their preferred treatment option for a molar tooth with a nonvital pulp (endodontics, extraction and various prosthetic restorative options) and WTP for this preferred option were elicited. Factors affecting preferred option and WTP were analysed using econometric modelling. RESULTS: Overall, 53% of the sample wished to save the tooth with a mean WTP of £373. The variance in WTP was high. Of those opting for extraction, the majority chose to leave a gap or have an implant. The preferred option was influenced by previous treatment experience. WTP was only influenced by having a low income. CONCLUSIONS: The high level of variance in WTP and its relatively unpredictable nature pose difficult questions for policy makers trying to ensure the delivery of an equitable service. For dentists, it is important not to make assumptions about patient preference and strength of preference when making decisions. Ideally, WTP values should be considered alongside effectiveness data, and those on costs, in policy making.

Design of an innovative paediatric capitation payment approach for public sector dentistry: an Australian experience.

AIM: The aim of this study was to trial the methodology and administration processes of a public paediatric capitation programme provided in the period 1 July 2011 to 31 December 2011 through a Bachelor of Oral Health programme in rural New South Wales (NSW), Australia, where access to public dental services is limited. BASIC RESEARCH DESIGN: The principal structure of the programme was the development of three diagnostic pathways: active caries and pain (Pathway A); active caries and no pain (Pathway B); and no active caries and no pain (Pathway C). In 2011, de-identified treatment data for NSW public dental services' patients under 18 years of age were analysed to identify the top 10 dental treatment items. These items were clustered according to the mean decayed and/or filled surface of patients under 18 years of age who had decayed, filled or missing teeth. Each treatment item was allocated 60% of the 2011 Australian Government Department of Veteran Affairs Schedule of Fees. CLINICAL SETTING: The programme was trialled in Charles Sturt University dental facility in Wagga Wagga, NSW. PARTICIPANTS: The programme targeted patients in the following age groups: 0-5 years; 6-11 years; and 12-17 years. RESULT: The 6-month trial provided 361 patients with a capitation pathway, at a total cost of $47,567.90, averaging $131.76 per capitation pathway. The total number of items provided (n=2,070) equated to an average of 5.7 items per capitation diagnostic pathway. CONCLUSION: This model offered an early entry point for paediatric patients to access dental care that addressed their needs, whilst being flexible enough to be fiscally attractive.

Dental attendance, perceptions of cost and self-care of school year 12 and 13 students: A focus on Southland, New Zealand.

BACKGROUND AND OBJECTIVES: Adolescents and emerging adults can provide dentists with many challenges. Little information is available on their perceptions of dental costs once they turn 18 and dentistry is no longer State-funded. The aim of this study was to explore the use of dental care by Southland students in years 12 and 13, their perceptions of the cost of four common dental procedures, self-related oral health and dental self-care habits, time off school related to dental problems, and knowledge and views regarding fluoride. METHODS: After ethical approval, a 26-question survey was conducted of all Southland students in years 12 and 13. Data were statistically analysed in SPSS version 20 with the alpha value set at 0.05. RESULTS: The participation rate was 49.6%. Regular attendance for examinations was reported by 77.5% with non-attendance mainly related to attitudes around lack of importance or necessity. Reported dental attendance varied according to gender, ethnicity and decile rating of school attended. Although some were accurate in their estimations of dental costs, the standard deviation for all procedures was large. The majority thought that costs put people off going to the dentist. While 74.8% brushed their teeth at least twice daily, only 26.6% flossed regularly. Knowledge regarding fluoride was lacking. CONCLUSIONS: It may be advantageous to include education regarding costs of dental care with patients of this age. This may motivate them to improve their self-care and ensure that their oral health is of a high standard before their dental needs are no longer State-funded.

The relative patient costs and availability of dental services, materials and equipment in public oral care facilities in Tanzania.

BACKGROUND: Patient charges and availability of dental services influence utilization of dental services. There is little available information on the cost of dental services and availability of materials and equipment in public dental facilities in Africa. This study aimed to determine the relative cost and availability of dental services, materials and equipment in public oral care facilities in Tanzania. The local factors affecting availability were also studied. METHODS: A survey of all district and regional dental clinics in selected regions was conducted in 2014. A total of 28/30 facilities participated in the study. A structured interview was undertaken amongst practitioners and clinic managers within the facilities. Daily resources for consumption (DRC) were used for estimation of patients' relative cost. DRC are the quantified average financial resources required for an adult Tanzanian's overall consumption per day. RESULTS: Tooth extractions were found to cost four times the DRC whereas restorations were 9-10 times the DRC. Studied facilities provided tooth extractions (100%), scaling (86%), fillings (79%), root canal treatment (46%) and fabrication of removable partial dentures (32%). The ratio of tooth fillings to extractions in the facilities was 1:16. Less than 50% of the facilities had any of the investigated dental materials consistently available throughout the year, and just three facilities had all the investigated equipment functional and in use. CONCLUSIONS: Dental materials and equipment availability, skills of the practitioners and the cost of services all play major roles in provision and utilization of comprehensive oral care. These factors are likely to be interlinked and should be taken into consideration when studying any of the factors individually.

An Efficient and Cost-Effective Technique to Construct an Intraoral Central Bearing Tracing Device.

Intraoral central bearing tracing has been shown to be a predictable way of recording and verifying centric relation position for patients. Existing tracing devices are challenging to use due to several significant clinical limitations. In comparison to commercially available counterparts, this article presents a technique that simplifies instrumentation and clinical steps to make an intraoral tracer for making centric relation records, determining occlusal vertical dimension, and detecting deflective occlusal contacts in edentulous patients.

A cost-effective treatment for severe generalized erosion and loss of vertical dimension of occlusion: laboratory-fabricated composite resin restorations.

This case report describes preventive and restorative treatment planning for a 56-year-old female patient with severe, chronic, poorly controlled gastroesophageal reflux disease and resulting loss of vertical dimension of occlusion. First, the demineralization process was controlled through collaboration with the patient's physician, and measures were taken to restore adequate stimulated salivary flow. Then, for financial reasons, indirect laboratory-fabricated composite resin restorations were adhesively bonded to replace lost tooth structure and reestablish the patient's collapsed vertical dimension. Indirect-laboratory fabricated restorations can be a cost-effective alternative to direct composite resin or all-ceramic restorations for the treatment of chronic severe erosion, but there are no long-term clinical reports in the current literature to support or contraindicate the use of indirect composites for this type of clinical application. Therefore, careful, long-term follow-up evaluations are planned for this patient.

Technique Tips--The Cost of One Post-Operative Sensitivity following Placement of a Posterior Composite Restoration.

Use a low shrinkage stress composite but, if not, use incremental placement and a layer of flowable at the gingival box; Ensure good bonding to dentine and enamel and avoid (over) etching the dentine; Ensure good adaptation at the gingival floor of a Class II box; Make sure that the restoration has received sufficient light; Provide good isolation; Use reliable and tested materials throughout.

The potential oral health impact of cost barriers to dental care: findings from a Canadian population-based study.

BACKGROUND: Prior to the 2007/09 Canadian Health Measures Survey, there was no nationally representative clinical data on the oral health of Canadians experiencing cost barriers to dental care. The aim of this study was to determine the oral health status and dental treatment needs of Canadians reporting cost barriers to dental care. METHODS: A secondary data analysis of the 2007/09 Canadian Health Measures Survey was undertaken using a sample of 5,586 Canadians aged 6 to 79. Chi square tests were conducted to test the association between reporting cost barriers to care and oral health outcomes. Logistic regressions were conducted to identify predictors of reporting cost barriers. RESULTS: Individuals who reported cost barriers to dental care had poorer oral health and more treatment needs compared to their counterparts. CONCLUSIONS: Avoiding dental care and/or foregoing recommended treatment because of cost may contribute to poor oral health. This study substantiates the potential likelihood of progressive dental problems caused by an inability to treat existing conditions due to financial barriers.

Cost-effectiveness of caries excavations in different risk groups - a micro-simulation study.

BACKGROUND: Whilst being the most prevalent disease worldwide, dental caries is increasingly concentrated in high-risk populations. New caries treatments should therefore be evaluated not only in terms of their cost-effectiveness in individuals, but also their effects on the distribution of costs and benefits across different populations. To treat deep caries, there are currently three strategies: selective (one-step incomplete), stepwise (two-step incomplete) and complete excavation. Building on prior research that found selective excavation generally cost-effective, we compared the costs-effectiveness of different excavations in low- and high-risk patients, hypothesizing that selective excavation had greater cost-effectiveness-advantages in patients with high compared with low risk. METHODS: An average tooth-level Markov-model was constructed following the posterior teeth in an initially 18-year old male individual, either with low or high risk, over his lifetime. Risk was assumed to be predicted by several parameters (oral hygiene, social position, dental service utilization), with evidence-based transition probabilities or hazard functions being adjusted for different risk status where applicable. Total lifetime treatment costs were estimated for German healthcare, with both mixed public-private and only private out-of-pocket costs being calculated. For cost-effectiveness-analysis, micro-simulations were performed and joint parameter uncertainty introduced by random sampling of probabilities. Cohort analyses were used for assessing the underlying reasons for potential differences between strategies and populations. RESULTS: Selective excavation was more effective and less costly than both alternatives regardless of an individual's risk. All three strategies were less effective and more costly in patients with high compared with low risk, whilst the differences between risk groups were smallest for selective excavation. Thus, the cost-effectiveness-advantages of selective excavation were more pronounced in high-risk groups, who also benefitted the most from reduced private out-of-pocket treatment costs. CONCLUSIONS: Whilst caries excavation does not tackle the underlying sources for both the development of caries lesions and the potential differences of individuals' risk status, selective excavation seems most suitable to treat deep lesions, especially in patients with high risk, who over-proportionally benefit from the resulting health-gains and cost-savings.

The FiCTION dental trial protocol - filling children's teeth: indicated or not?

BACKGROUND: There is a lack of evidence for effective management of dental caries (decay) in children's primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools' teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned. The FiCTION trial addresses the Health Technology Assessment (HTA) Programme's commissioning brief and research question "What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?" It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations. METHODS/DESIGN: This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3-7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone. Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires. The primary outcome measure is the incidence of either pain or infection related to dental caries. Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists' preferences. DISCUSSION: FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children's primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients. TRIAL REGISTRATION: Protocol ID: NCTU: ISRCTN77044005.