Comparison of pain perception during miniscrew placement in orthodontic patients with a visual analog scale survey between compound topical and needle-injected anesthetics: A crossover, prospective, randomized clinical trial

Abstract

Introduction: The use of a compound topical anesthetic (CTA) instead of an injection of a local anesthetic for placing miniscrew implants offers advantages to both the clinician and the patient. The purpose of this crossover, prospective, randomized clinical trial was to compare the clinical effectiveness of a CTA with that of a needle injection of local anesthetic for miniscrew placement.

Methods: Twenty-four orthodontic patients in a university clinic were recruited; they required bilateral buccal miniscrews for orthodontic anchorage. Eligibility criteria included healthy patients with no special needs; over 8 years of age and 25 pounds; not taking sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines; and not allergic to ester-type local anesthetics or any of the other materials used in the study. A computer generated a randomization list. The allocation was randomized by anesthetic protocol and side of the mouth, and was restricted to achieve balance by treatment and side of the mouth. No allocation concealment was applied. Associated with each randomized number was the subjects' assignment into 1 of 4 groups divided by the side of first miniscrew placement and the type of anesthetic. Blinding was done only for data analysis because of clinical limitations. Each patient received a CTA on one side and an injection of anesthetic on the other before miniscrew placement in a crossover study design. The outcome was assessed by measuring pain levels with a 100-mm visual analog scale at 5 time points. Anesthetic failures occurred when the miniscrew could not be fully comfortably placed with a given anesthetic. Data were organized by visual analog scale time points, and descriptive statistics were calculated. A factorial repeated-measures analysis of variance was used to determine any differences.

Results: Twenty-seven patients were assessed for eligibility, and 24 agreed to participate in the study. Patients did not distinguish any differences in pain between the application of the CTA and the injection before or during anesthetic placement, but they experienced more pain with the CTA during miniscrew placement. The mean difference for the entire procedure between the 2 anesthesia types was 24.6 units, and the 95% confidence interval was 18.8 to 30.4, a statistically significant finding (P = 0.0002). The CTA was still viewed as more painful 1 month after the procedures. Significantly more anesthetic failures occurred with the CTA (41.6%) than with the injection (0%). No serious harm was observed in any patient; when significant pain was observed with the CTA, a needle injection of local anesthetic was administered.

Conclusions: CTAs provided less predictable, often inadequate, and less comfortable anesthesia than an injection of a local anesthetic for managing patient discomfort during miniscrew placement in buccal sites.

Registration: This trial was not registered.

Protocol: The protocol was determined and approved by the research committee and institutional review board before the trial.

Funding: No external funding was used other than the donation of the miniscrews from Rocky Mountain Orthodontics, and no conflict of interest was declared.