Treatment outcomes of two surgical techniques in secondary reconstruction of unilateral cleft lip and ala nasi utilizing anthropometry assessment: a randomized controlled trial.

Background: An orofacial cleft significantly impacts the oral health-related quality of life of children and teenagers. Secondary reconstruction is a more complex procedure due to tissue deficiency and scarring. The study aimed to evaluate the use of Pfeifer's wave-line incision method and the rotational flap method in the secondary reconstruction of unilateral lip clefts in patients with unilateral cleft lip and ala nasi aged 5-25 years utilizing anthropometry assessment.

Methods: It was a double-blinded, randomized, parallel-group, active-controlled trial with two arms. Twenty-four patients were randomly divided into two groups. Group 1: Rotational flap method. Group 2: Control group, Pfeifer's wave-line incision method. The following anthropometric measurements were considered: Lb(X):En-En: The horizontal position of the center of the cupid's bow. Ch-Lt(l:r): The distance between the cheilion and the tip of the cupid's bow. Lt-Lb(l:r): The length of the cupid's bow. Lt(Y)(l:r): The size of the upper lip. Lt-Lt'(l:r): The height of the vermilion at the tip of the cupid's bow. Photographs were performed according to the follow-up periods: At the baseline and before surgery (t₀). Immediately after surgery (t₁). Two weeks after surgery (t₂). Six months after surgery (t₃).

Results: The rotational flap method did not outperform Pfeifer's method in the studied anthropometric measurements. In the rotational flap method group, there was a significant improvement in the mean value of Ch-Lt(l:r) from t₀ (1.156 ± 0.206) to t₃ (0.962 ± 0.098), and in the average value of Lt(Y)(l:r) from t₀ (0.944 ± 0.023) to t₃ (0.990 ± 0.011) (p < 0.05). In Pfeifer's method group, the mean value of Ch-Lt(l:r) was (1.141 ± 0.158) at t₀, and then improved to become (1.007 ± 0.084) at t₃ (p < 0.05), the average value of Ch-Lt(l:r) at t₀ was (0.942 ± 0.026), which improved to (0.991 ± 0.012) at t₃, and the average value of Lt-Lt'(l:r) increased from t₀ (1.308 ± 1.174) to t₃ (1.050 ± 0.054) (p < 0.05).

Conclusion: Pfeifer's wave-line incision and rotational flap methods achieve similar aesthetic results in the appearance of the lip or Cupid's bow after a 6-month follow-up.

Trial registration: ISRCTN registry, ISRCTN36320776, registered 06 November 2024.