Trial reportClinical oral investigations2025
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.
Trial report in Clinical oral investigations, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
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Abstract
aimTo 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 RELEVANCE: MBI + 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.
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