Journal of Isfahan Medical School

Journal of Isfahan Medical School

The Effect of Using Hydroxyapatite Mesh on the Occurrence of Fistula in Patients Undergoing Primary Palatoplasty by the Sommerlad Intravelar Veloplasty: A Randomized Clinical Trial

Document Type : Original Article(s)

Authors
Hossein Abdali 1
Milad Golshani 1
Amirhossein Fasahat 1
Sayed Ali Poursamar 2
Mohammad Abedian 3
1 Craniofacial and Cleft Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Department of Biomaterials, Nanotechnology, and Tissue Engineering, School of Advanced Technologies in Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
3 General Surgeon, Burjeel Group, Abu dhabi, UAE
10.48305/jims.v44.i872.1327
Abstract
Introduction: Cleft lip and palate is known as one of the most common congenital malformations. This study evaluates the effect of using hydroxyapatite in primary microscopic palatoplasty to prevent postoperative fistula.
Methods: This randomized, double-blind clinical trial was conducted from 2023 to 2024 at the "Cleft Lip and Palate Center" of Isfahan University of Medical Sciences. The surgical technique of intravalvar Somerlad valvuloplasty included separation of the oral and nasal mucosa and then repair of the nasal mucosa. In the intervention group, a hydroxyapatite mesh was placed on the nasal mucosa of the patients and then the oral mucosa was repaired. The patients were then followed up at 3 and 6 months after surgery to assess the incidence of fistula.
Findings: At the first follow-up, the incidence of fistula was higher in the no-mesh group (18.8%) than in the mesh group (3.1%) (p = 0.104). However, the incidence of fistula at the second follow-up did not show a significant difference between the two groups (34.4% vs. 6.2%) (p = 0.011). From the first follow-up to the second follow-up, the incidence of fistula in the non-mesh group increased slightly (from 18.8% to 34.4%) (p = 0.063). However, in the mesh group, the incidence of fistula did not show a significant increase from the first follow-up to the second follow-up (from 3.1% to 6.2%) (p = 0.999).
Conclusion: The use of hydroxyapatite mesh in primary palatoplasty has the potential to significantly reduce the incidence of postoperative fistula.

Highlights

Hossein Abdali: PubMed,  Google Scholar

Amirhossein Fasahat: PubMed,  Google Scholar

Seyed Ali Poursamar: PubMed,  Google Scholar

Keywords
Left Palate
Primary Palatoplasty
Sommerled Intravelar Veloplasty
Hydroxyapatite
Subjects
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Journal of Isfahan Medical School
Volume 44, Issue 872
4th Week, September
September and October 2026
Pages 1327-1333

  • Receive Date 26 August 2025
  • Accept Date 01 October 2025