Intraseptal injection as an alternative for palatal infiltration in vital maxillary first permanent molars of 6- to 18-year-old patients: a non-inferiority randomised controlled trial
摘要
To compare pulpal anaesthesia and injection pain between maxillary buccal infiltration with intraseptal (MBI + ISI) or palatal (MBI + PI) infiltration in the vital maxillary first permanent molars of 6- to 18-year-old patients.
Materials and methodsThe primary outcome of this non-inferiority randomised controlled trial was pulpal anaesthesia, which was assessed pre-operatively using a cold test and intra-operatively based on patients’ reported pain on the Wong–Baker FACES Pain Scale (WBFPS) and requests for supplementary injections. This trial hypothesised that the pulpal anaesthesia success of the MBI + ISI was non-inferior to that of the MBI + PI by a margin of − 15%. The secondary outcome was injection pain, reported by patients on the WBFPS, with success defined as a WBFPS score ≤ 4.
ResultsThe final sample comprised 22 boys and 35 girls aged 6.8 to 16.2 years (mean: 10.5 ± 1.9 years) and included 57 teeth (28 in the MBI + ISI group and 29 in the MBI + PI group). Baseline characteristics were similar between groups. The pulpal anaesthesia success was 78.6% in the MBI + ISI group and 82.8% in the MBI + PI group (risk difference [RD]: −4.2%, 95% confidence interval [CI]: −24.7%–16.3%, p = 0.689). For injection pain, success was 84.9% in the MBI + ISI group and 29.0% in the MBI + PI group (RD: 55.8%, 95% CI: 35.7%–75.9%, p < 0.001).
ConclusionCompared to MBI + PI, non-inferiority of pulpal anaesthesia in MBI + ISI was not demonstrated; however, MBI + ISI reduced injection pain and achieved similar success rates of pulpal anaesthesia, suggesting it may be considered in selected paediatric cases.
Clinical relevanceMBI + ISI offers comparable pulpal anaesthesia success to MBI + PI while significantly reducing injection pain. This makes it a valuable alternative for anaesthetising vital maxillary first permanent molars in children and adolescents, particularly in cases where minimising discomfort is a priority.