Evaluation of Patient-Centered Outcomes Associated With the Acceleration of en-Masse Retraction of Upper Anterior Teeth Assisted by Flapless Corticotomy Compared to Traditional Corticotomy: A Two-Arm Randomized Controlled Trial

Objective: This study aimed to assess the levels of pain, discomfort, and functional impairment associated with the en-masse retraction of the upper anterior teeth when treating Class II division 1 malocclusion patients using traditional corticotomy or flapless corticotomy. In addition, an assessment of patients' satisfaction with the selected surgical intervention was undertaken at one-month post-operatively.

Materials and methods: The study sample comprised 40 patients with Class II division 1 malocclusion, randomly assigned to either the traditional corticotomy group (n=20) or the flapless corticotomy group (n=20). Patients underwent extraction of the maxillary first premolars, and orthodontic mini-screws were placed between the maxillary second premolars and the first molars for skeletal anchorage. An en-masse retraction was accomplished in both groups. Patients were asked to fill in a questionnaire at 24 hours (T1), four days (T2), seven days (T3), 14 days (T4), and 28 days (T5) after the surgical intervention using standardized questionnaires. Most questions were answered on a visual analog scale where zero scores meant the absence of pain, discomfort, or functional impairment, and 100 scores meant the worst feelings of these traits.

Results: All patients in both groups entered data analysis with no dropouts. All measured levels were significantly greater in the traditional corticotomy group during the first two weeks following the corticotomy intervention in terms of pain perception (P˂0.001), discomfort (P=0.004), and difficulty in chewing (P=0.015). Additionally, during the first week following corticotomy, levels of perception of discomfort (P˂0.001), difficulty in swallowing (P=0.001), and limitation of jaw movement (P˂0.001) were significantly greater in the traditional corticotomy group. Patient satisfaction, the recommendation to a friend, and acceptance of flapless corticotomy were significantly greater than traditional corticotomy (P=0.002, P=0.001, respectively). 78% of patients in the traditional corticotomy group considered it more discomfort than a tooth extraction, while 50% of patients in the flapless corticotomy group considered tooth extraction more discomfort, with a significant difference between the two groups (P=0.001).

Conclusions: The levels of negative patients' reported outcomes were significantly smaller with flapless corticotomy than with traditional corticotomy. Traditional corticotomy was associated with mild to moderate levels of pain, swallowing difficulty, moderate levels of discomfort, chewing difficulty, and jaw movement limitation after 24 hours of the surgical procedure. In contrast, flapless corticotomy was less problematic and associated with mild pain, swelling, chewing difficulty, jaw movement limitation, and swallowing difficulty at the same assessment time. Patient satisfaction, acceptance, and recommendation to a friend were greater for flapless corticotomy than traditional intervention.