Global abstract: The research presented in this thesis is in several parts. Firstly, the aim of systematic review was to systematically review available evidence on the efficacy of two local anaesthetic solutions lidocaine and articaine used for dental treatment in children. The findings from this review served as a basis for the next phase of the project, which was to address the deficiencies identified from the systematic review. This took the form of a Randomised Controlled Trial, the aim of which was to carry out an equivalence parallel prospective, randomised, controlled study, in order to evaluate and compare the anaesthetic efficacy of mandibular infiltration using 4% articaine (1:100,000 epinephrine) with mandibular nerve block using 2% lidocaine (1:80,000 epinephrine) in the extraction and restoration of mandibular primary molars. The translational intention was to be able to recommend the most effective and acceptable method of achieving anaesthesia for dental treatment of mandibular primary molars in children.
In addition, a mixed method research strategy was implemented, in order to assess and explore the child’s experience associated with dental injection, and compare the two different techniques that were used (buccal infiltration and inferior dental nerve block). This comparison was in terms of children acceptance as well as parent satisfaction of their child’s dental treatment under local anaesthesia and their perception of the impact of this treatment on their child.
Methods: Systematic review: A systematic search was conducted on Cochrane CENTRAL Register of Controlled Trials, MEDLINE (OVID; 1950 to June 2013), Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOhost; 1982 to June 2013), EMBASE (OVID; 1980 to June 2013), SCI-EXPANDED (ISI Web of Knowledge; 1900 to June 2013), key journals, and previous review bibliographies through June 2013. No restrictions were placed on years, language or publication status. Original research studies that compared articaine with lidocaine in children dental treatment were included and methodological quality assessment including assessment of risk of bias was carried out for each of the included studies.
RCT: In total 98 children aged 5–9 years old were randomly assigned into two groups: one group (treatment group) received mandibular infiltration with 4% articaine with 1:100,000 epinephrine; the other group (control group) received an inferior alveolar nerve block with 2% lidocaine with 1:80,000 epinephrine. All local anaesthetic injections were given by a single operator, who had the role of assessing the presence/absence of pain as well as the child’s behaviour during the injection and treatment procedures (using W-BFRS, VAS and Frankl Behaviour Scale). Each child received one treatment for one tooth only.
Qualitative sub-study: Concurrent mixed method data collection strategies were used. The qualitative and quantitative data were collected from the same participants as well as in the same timeframe. Thematic analysis was performed on the semi- structured interviews.
Results: Systematic review: Electronic searching identified 520 publications. After the primary and secondary assessment process, only three studies were included in the final analysis. The RCTs included in this review investigated the efficacy of local anaesthetic solutions when given as a combination of both techniques, local infiltration as well as block anaesthesia. The data analyses showed superiority of articaine over that of lidocaine in terms of achieving anaesthetic success, although these results were not statistically significant.
RCT: During the injection phase the absolute differences between the two anaesthetic techniques using W-BFRS VAS and behaviour scales was zero (no difference), 0.060 (95% CI -0.110 to 0.230) and -0.080 (95% CI -0.190 to 0.030) respectively. During the treatment phase, the absolute difference were -0.020 (95% CI -0.180 to 0.140), -0.040 (95% CI -0.220 to 0.150) and zero (no difference). The equivalence margin was set at ± 0.2 and all comparisons showed equivalence of the two treatments except for the comparison of VAS during injection and W-BFRS during treatment with the 95% confidence intervals exceeding the equivalence margin.
Qualitative sub-study: A total of 42 (56%) participants in the qualitative part of the study, were in articaine group while 31 (41%) were in lidocaine group. Only two of the participants (3%) had received both local anaesthetics. Parent’s responses to the questionnaire reflected their opinion based on their observation of the dental treatment. Majority of the parents were happy about the treatment in general. The children’s responses were very positive as well.
The questionnaire/interviews with the children, parents, along with the dentist’s comments, allowed the development of three major themes addressing the aims and purposes of the study. The three major themes emerged were: Firstly, “Experience of the anaesthetic procedures”. Second major theme “Ease vs difficulty of the dental treatment” and the third major theme was “Perception of the dentist approach during the treatment”.
Conclusion: The quality of the included RCTs in the systematic review was generally inadequate. All the included studies had several limitations in reporting which indicated a need for a randomised clinical trial with standardised methodology to address these limitations.
The findings of the systematic review indicated that, articaine and lidocaine presented similar efficacy when used as infiltration and blocks respectively for routine dental treatments. The effect of numbness of soft tissues was longer using articaine than lidocaine, and few adverse events were reported following the use of both solutions. The results from this review indicate that articaine injections can cause slightly more post injection pain in the area injected than lignocaine, the difference was not statistically significant.
Overall, the results of the present RCT pointed out that it would be acceptable to carry out invasive dental treatment for mandibular molars with the administration of infiltration with buccal intrapapillary infiltration using 4% articaine instead of the traditional method of inferior dental block using lidocaine, which many children find difficult to cope with.
Considering the findings from the survey, along with the results from the questionnaire/interview, it was established that, the reactions of the patients with both of the local anaesthetics were very similar. The interview findings added meaning and depth to the survey findings, in terms of explaining and clarifying the children’s responses and answers. Parents/children reported a high degree of satisfaction with the treatment outcomes. The satisfaction expressed by parents/children can have a positive impact on the children’s future dental treatment.
Registration: SR Registration: PROSPERO registration: CRD42013004620. Trial registration: EudraCT number: 2011-004711-23
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)