Evaluation of intraosseous computerized injection system (QuickSleeper™) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial.

BACKGROUND: Conventional infiltration anaesthesia (CIA) is the most frequently used in paediatric oral health care. However, other techniques are available, such as intraosseous anaesthesia (IOA), that can beneficiate from newly developed technologies. AIM: To compare the pain caused by CIA and IOA delivered by the computerized system (QuickSleeper™) in children. DESIGN: We used an innovative design consisting in simultaneously conducting a multicentre split-mouth and parallel-arm randomized controlled trial (RCT) to allow for increased power. The primary outcome was pain reported by the patient on a visual analogue scale (0-10 cm) concerning the insertion of the needle and injection. RESULTS: A total of 30 children were included in the split-mouth RCT and 128 in the parallel-arm RCT. We combined treatment effect estimates by using an inverse-variance weighting meta-analysis approach. Pain scores were significantly decreased with IOA vs CIA (mean difference -0.69 cm, 95% confidence intervals -1.13 to -0.25 cm). For each patient enrolled in the split-mouth RCT, about five were enrolled in the parallel-arm RCT, which allowed for not losing any eligible patients. CONCLUSION: Pain during the insertion of the needle and injection was less with IOA vs CIA in children. The design of this study allowed for increasing statistical power and using all generated evidence. (ClinicalTrials.gov NCT02084433).

Pulp treatment for extensive decay in primary teeth.

BACKGROUND: In children, dental caries (tooth decay) is among the most prevalent chronic diseases worldwide. Pulp interventions are indicated for extensive tooth decay. Depending on the severity of the disease, three pulp treatment techniques are available: direct pulp capping, pulpotomy and pulpectomy. After treatment, the cavity is filled with a medicament. Materials commonly used include mineral trioxide aggregate (MTA), calcium hydroxide, formocresol or ferric sulphate.This is an update of a Cochrane Review published in 2014 when insufficient evidence was found to clearly identify one superior pulpotomy medicament and technique. OBJECTIVES: To assess the effects of different pulp treatment techniques and associated medicaments for the treatment of extensive decay in primary teeth. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the Cochrane Oral Health Group's Trials Register (to 10 August 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2017, Issue 7), MEDLINE Ovid (1946 to 10 August 2017), Embase Ovid (1980 to 10 August 2017) and the Web of Science (1945 to 10 August 2017). OpenGrey was searched for grey literature. The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing interventions that combined a pulp treatment technique with a medicament or device in children with extensive decay in the dental pulp of their primary teeth. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed 'Risk of bias'. We contacted authors of RCTs for additional information when necessary. The primary outcomes were clinical failure and radiological failure, as defined in trials, at six, 12 and 24 months. We performed data synthesis with pair-wise meta-analyses using fixed-effect models. We assessed statistical heterogeneity by using I² coefficients. MAIN RESULTS: We included 40 new trials bringing the total to 87 included trials (7140 randomised teeth) for this update. All were small, single-centre trials (median number of randomised teeth = 68). All trials were assessed at unclear or high risk of bias.The 87 trials examined 125 different comparisons: 75 comparisons of different medicaments or techniques for pulpotomy; 25 comparisons of different medicaments for pulpectomy; four comparisons of pulpotomy and pulpectomy; and 21 comparisons of different medicaments for direct pulp capping.The proportion of clinical failures and radiological failures was low in all trials. In many trials, there were either no clinical failures or no radiographic failures in either study arm.For pulpotomy, we assessed three comparisons as providing moderate-quality evidence. Compared with formocresol, MTA reduced both clinical and radiological failures, with a statistically significant difference at 12 months for clinical failure and at six, 12 and 24 months for radiological failure (12 trials, 740 participants). Compared with calcium hydroxide, MTA reduced both clinical and radiological failures, with statistically significant differences for clinical failure at 12 and 24 months. MTA also appeared to reduce radiological failure at six, 12 and 24 months (four trials, 150 participants) (low-quality evidence). When comparing calcium hydroxide with formocresol, there was a statistically significant difference in favour of formocresol for clinical failure at six and 12 months and radiological failure at six, 12 and 24 months (six trials (one with no failures), 332 participants).Regarding pulpectomy, we found moderate-quality evidence for two comparisons. The comparison between Metapex and zinc oxide and eugenol (ZOE) paste was inconclusive, with no clear evidence of a difference between the interventions for failure at 6 or 12 months (two trials, 62 participants). Similarly inconclusive, there was no clear evidence of a difference in failure between Endoflas and ZOE (outcomes measured at 6 months; two trials, 80 participants). There was low-quality evidence of a difference in failure at 12 months that suggested ZOE paste may be better than Vitapex (calcium hydroxide/iodoform) paste (two trials, 161 participants).Regarding direct pulp capping, the small number of studies undertaking the same comparison limits any interpretation. We assessed the quality of the evidence as low or very low for all comparisons. One trial appeared to favour formocresol over calcium hydroxide; however, there are safety concerns about formocresol. AUTHORS' CONCLUSIONS: Pulp treatment for extensive decay in primary teeth is generally successful. Many included trials had no clinical or radiological failures in either trial arm, and the overall proportion of failures was low. Any future trials in this area would require a very large sample size and follow up of a minimum of one year.The evidence suggests MTA may be the most efficacious medicament to heal the root pulp after pulpotomy of a deciduous tooth. As MTA is relatively expensive, future research could be undertaken to confirm if Biodentine, enamel matrix derivative, laser treatment or Ankaferd Blood Stopper are acceptable second choices, and whether, where none of these treatments can be used, application of sodium hypochlorite is the safest option. Formocresol, though effective, has known concerns about toxicity.Regarding pulpectomy, there is no conclusive evidence that one medicament or technique is superior to another, and so the choice of medicament remains at the clinician's discretion. Research could be undertaken to confirm if ZOE paste is more effective than Vitapex and to evaluate other alternatives.Regarding direct pulp capping, the small number of studies and low quality of the evidence limited interpretation. Formocresol may be more successful than calcium hydroxide; however, given its toxicity, any future research should focus on alternatives.

Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial.

INTRODUCTION: Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the computerised QuickSleeper system, in children and adolescents. METHODS AND ANALYSIS: Inclusion criteria are patients 7-15 years old with at least 2 first permanent molars belonging to the same dental arch (for the split-mouth RCT) or with a first permanent molar (for the parallel-arm RCT) requiring conservative or endodontic treatment limited to pulpotomy. The setting of this study is the Department of Paediatric Dentistry at 3 University dental hospitals in France. The primary outcome measure will be pain reported by the patient on a visual analogue scale concerning the insertion of the needle and the injection/infiltration. Secondary outcomes are latency, need for additional anaesthesia during the treatment and pain felt during the treatment. We will use a computer-generated permuted-block randomisation sequence for allocation to anaesthesia groups. The random sequences will be stratified by centre (and by dental arch for the parallel-arm RCT). Only participants will be blinded to group assignment. Data will be analysed by the intent-to-treat principle. In all, 160 patients will be included (30 in the split-mouth RCT, 130 in the parallel-arm RCT). ETHICS AND DISSEMINATION: This protocol has been approved by the French ethics committee for the protection of people (Comité de Protection des Personnes, Ile de France I) and will be conducted in full accordance with accepted ethical principles. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02084433.

Pulp treatment for extensive decay in primary teeth.

BACKGROUND: In children, dental caries is among the most prevalent chronic diseases worldwide. Pulp interventions are indicated for extensive tooth decay. Depending on the severity of the disease, three pulp treatment techniques are available: direct pulp capping, pulpotomy and pulpectomy. After treatment, the cavity is filled with a medicament.This is an update of a Cochrane review first published in 2003. The previous review found insufficient evidence regarding the relative efficacy of these interventions, combining one pulp treatment technique and one medicament. OBJECTIVES: To assess the effects of different pulp treatment techniques and associated medicaments for the treatment of extensive decay in primary teeth. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 25 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE via OVID (1946 to 25 October 2013), EMBASE via OVID (1980 to 25 October 2013) and the Web of Science (1945 to 25 October 2013). We searched OpenGrey for grey literature and the US National Institutes of Health Trials Register and the World Health Organization (WHO) Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Eligible studies were randomised controlled trials comparing different pulp interventions combining a pulp treatment technique and a medicament in children with extensive decay involving dental pulp in primary teeth. DATA COLLECTION AND ANALYSIS: Two review authors independently carried out data extraction and risk of bias assessment in duplicate. We contacted authors of randomised controlled trials for additional information if necessary. The primary outcomes were clinical failure and radiological failure, as defined in trials, at six, 12 and 24 months. We performed data synthesis with pairwise meta-analyses using fixed-effect models. We assessed statistical heterogeneity using by I(2) coefficients. MAIN RESULTS: We included 47 trials (3910 randomised teeth) compared to three trials in the previous version of the review published in 2003. All trials were single centre and small sized (median number of randomised teeth 68). Overall, the risk of bias was low in only one trial with all other trials being at unclear or high risk of bias. The overall quality of the evidence was low. The 47 trials examined 53 different comparisons: 25 comparisons between different medicaments/techniques for pulpotomy, 13 comparisons between different medicaments for pulpectomy, 13 comparisons between different medicaments for direct pulp capping and two comparisons between pulpotomy and pulpectomy. Regarding pulpotomy, 14 trials compared mineral trioxide aggregate (MTA) with formocresol (FC). MTA reduced both clinical and radiological failures at six, 12 and 24 months, although the difference was not statistically significant. MTA also showed favourable results for all secondary outcomes measured, although again, differences between MTA and FC were not statistically significant (with the exception of pathological root resorption at 24 months and dentine bridge formation at six months). MTA showed favourable results compared with calcium hydroxide (CH) (two trials) for all outcomes measured, but the differences were not statistically significant (with the exception of radiological failure at 12 months). When comparing MTA with ferric sulphate (FS) (three trials), MTA had statistically significantly fewer clinical, radiological and overall failures at 24 months. This difference was not shown at six or 12 months.FC was compared with CH in seven trials and with FS in seven trials. There was a statistically significant difference in favour of FC for clinical failure at six and 12 months, and radiological failure at six, 12 and 24 months. FC also showed favourable results for all secondary outcomes measured, although differences between FC and CH were not consistently statistically significant across time points. The comparisons between FC and FS showed no statistically significantly difference between the two medicaments for any outcome at any time point.For all other comparisons of medicaments used during pulpotomies, pulpectomies or direct pulp capping, the small numbers of studies and the inconsistency in results limits any interpretation. AUTHORS' CONCLUSIONS: We found no evidence to identify one superior pulpotomy medicament and technique clearly. Two medicaments may be preferable: MTA or FS. The cost of MTA may preclude its clinical use and therefore FS could be used in such situations. Regarding other comparisons for pulpectomies or direct pulp capping, the small numbers of studies undertaking the same comparison limits any interpretation.