Journal of Cranio-Maxillo-Facial Surgery 47 (2019) 902e908 Contents lists available at ScienceDirect Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com Review Influence of vomer flap on craniofacial growth in patients with cleft lip and palate: A systematic review * Lurian Minatel ,Jessica Marcela de Luna Gomes, Cleidiel Aparecido Araújo Lemos, Joao~ Pedro Justino de Oliveira Limírio, Eduardo Piza Pellizzer Department of Dental Materials and Prosthodontics, Sao Paulo State University (UNESP), School of Dentistry, Sao Paulo, Brazil article info abstract Article history: The aim of this review was to evaluate the impact of the vomer flap on craniofacial growth in patients Paper received 23 November 2018 with cleft lip and palate. The review was conducted according to the PRISMA checklist and is registered Accepted 11 March 2019 in the International Prospective Register of Systematic Reviews (PROSPERO d CRD42018095714). Two Available online 15 March 2019 investigators performed the research using the PubMed/MEDLINE, Embase, and Web of Science data- bases for studies published until November 2018. The focused question was ‘Does the vomer flap have a Keywords: lesser impact on craniofacial growth in patients with cleft lip and palate?’. A total of 13 articles was Cleft lip selected for this review, comparing the vomer flap technique with other flap surgery techniques. The Cleft palate Vomer flap outcomes analyzed were: facial development (primary outcome); and the growth of the maxilla and fi Growth and development mandible, occlusion, occurrence of stula, and speech development (secondary outcomes). It was Systematic review concluded that there is no difference in impact between vomer flap and the other flap surgery techniques on craniofacial development. © 2019 Published by Elsevier Ltd on behalf of European Association for Cranio-Maxillo-Facial Surgery. 1. Introduction some studies have proposed techniques to reduce scarring in the palate (Fudalej et al., 2012). In addition, some authors have re- The main objective of surgical treatment in patients with cleft ported that surgical time might also be an influencing factor lip and palate is the anatomical closure of the defect in order to limiting maxillary growth (Graber, 1949; Bardach et al.,1984; Friede prevent impairment of speech development and feeding, while and Enemark, 2001). ensuring that there is no significant restriction of maxillary growth, The vomer flap surgical technique for closure of the hard palate which in turn may be influenced by the choice of surgical protocol has been used since 1926, and has undergone subsequent modifi- (Rohrich et al., 2000; Shaw et al., 1992; Silva Filho et al., 2001, cations (Liao et al., 2014; de Jong and Breugem, 2014). The advan- Agrawal, 2009). Therefore, several protocols have been proposed tages of this type of flap are ease of execution, minimal trauma to for the treatment of patients with cleft lip and palate in an attempt tissues, and reduced surgical time. Additionally, the flap is located to minimize the influence of surgery on craniofacial growth. The in a region of good vascularization, and provides effective nasal protocols vary according to the techniques employed, period of coverage in most types of fissure, thereby proving to be useful in intervention, treatment sequence for lip, hard, and soft palate the majority of patients with cleft lip and palate (Kobus, 1984; correction, and presurgical orthodontic and orthopedic in- Agrawal and Panda, 2006). terventions (Silva Filho et al., 2001; Kulewicz and Dudkiewicz, The treatment of patients with cleft lip and palate is complex, 2010). and although there are a large number of surgical procedures in It has been hypothesized that the scars caused by palatoplasty use, there is no consensus regarding the most effective technique. procedures contribute to maxillary growth disturbances. Therefore, This may be attributed to the numerous criteria that need to be considered and evaluated in formulating the ideal treatment method (Rohrich et al., 2000; Agrawal, 2009; Kulewicz and Dudkiewicz, 2010). Therefore, this systematic review was carried * d Corresponding author. Department of Materials and Prosthodontics, UNESP out to establish whether the vomer flap has a lesser impact on Univ Estadual Paulista, Jose Bonifacio Street, 1193, 16015-050, Araçatuba, Sao~ Paulo, Brazil. Fax: þ551836363297. craniofacial growth in patients with cleft lip and palate. E-mail address: [email protected] (L. Minatel). https://doi.org/10.1016/j.jcms.2019.03.011 1010-5182/© 2019 Published by Elsevier Ltd on behalf of European Association for Cranio-Maxillo-Facial Surgery. L. Minatel et al. / Journal of Cranio-Maxillo-Facial Surgery 47 (2019) 902e908 903 2. Materials and methods one study, by Ganesh et al. (2015), which was a randomized controlled trial (RCT), the Cochrane scale was used to assess the risk 2.1. Registry protocol of bias. This systematic review was performed according to the 2.6. Additional analyses Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) checklist (Moher et al., 2010). Furthermore, The kappa statistic (k) was used to determine inter-reader the methods used in this systematic review were registered in the agreement during the article selection process in the database International Prospective Register of Systematic Reviews (PROS- search. PERO d CRD42018095714). 3. Results 2.2. Eligibility criteria 3.1. Study selection The study focused on addressing the following question: ‘Does the vomer flap have a lesser impact on craniofacial growth in pa- The database search retrieved 243 articles: 85 from PubMed/ tients with cleft lip and palate?‘. The PICO tool was used to identify MEDLINE, 71 from Web of Science, and 87 from Embase. After the the components of clinical evidence, which are as follows: removal of duplicates, 89 studies remained. After reading the titles and abstracts, 52 studies were selected for complete reading, of 1. Population d non-syndromic patients with cleft lip and palate. which 39 were excluded using the eligibility criteria. Finally, 13 2. Intervention d patients who underwent vomer flap for studies were selected for this review (Fig. 1). correction of cleft in the hard palate. The inter-investigator agreement for articles selected from 3. Comparison d patients who underwent other surgical tech- PubMed/MEDLINE (k ¼ 0.82), Embase (k ¼ 0.89), and the Web of niques for correction of cleft in the hard palate. Science (k ¼ 0.92) indicated a high level of agreement (Landis and 4. Outcome d craniofacial growth (primary outcome); speech Koch, 1977). development and occurrence of fistula (secondary outcomes). Randomized controlled trials (RCTs) and prospective and 3.2. Study characteristics retrospective studies were included in this review (retrospective studies were included because of the limited number of RCTs on the Of the 13 studies included in this review (Jonsson et al., 1980; subject). In vitro studies, animal studies, case series, case reports, Tanino et al., 1997; Silva Filho et al., 2001; Friede and Enemark, and systematic reviews were excluded. 2001; Melissaratou and Friede, 2002; Johnston et al., 2004; Kulewicz and Dudkiewicz, 2010; Fudalej et al., 2012, 2013; Liao et 2.3. Information sources and search al., 2014; Ganesh et al., 2015; Xu et al., 2015; Rossell-Perry, 2018), one was a randomized clinical study (Ganesh et al., 2015) while the Two independent authors (LM, CAAL) conducted an electronic search of the PubMed/MEDLINE, Embase, and Web of Science da- tabases for articles published until March 2018. The keywords used were: ((“cleft lip"[MeSH Terms] OR (“cleft"[All Fields] AND “lip"[All Fields]) OR “cleft lip"[All Fields]) AND (“palate"[MeSH Terms] OR “palate"[All Fields]) AND (“vomer"[MeSH Terms] OR “vomer"[All Fields]) AND (“surgical flaps"[MeSH Terms] OR (“surgical"[All Fields] AND “flaps"[All Fields]) OR “surgical flaps"[All Fields] OR “flap"[All Fields])) OR ((“cleft palate"[MeSH Terms] OR (“cleft"[All Fields] AND “palate"[All Fields]) OR “cleft palate"[All Fields]) AND (“vomer"[MeSH Terms] OR “vomer"[All Fields]) AND (“surgical flaps"[MeSH Terms] OR (“surgical"[All Fields] AND “flaps"[All Fields]) OR “surgical flaps"[All Fields] OR “flap"[All Fields])). 2.4. Data collection process One author (LM) collected relevant information from the articles and a second author (CAAL) reviewed all the information collected. Careful analyses were carried out in cases of author disagreement, which were resolved through discussion with a third author (JMLG) until a consensus was reached. 2.5. Risk of bias Two investigators (LM and JMLG) assessed the methodological quality of the studies using the Newcastle-Ottawa scale (NOS) for cohort studies, which is based on three major components: selec- tion, comparability, and outcome. According to the NOS, a maximum of nine stars can be given to a study, and represents the highest quality. A score of five or fewer stars indicates a high risk of bias, while a score of six or more stars indicates a low risk of bias. In Fig. 1. Flowchart of the search strategy. 904 L. Minatel et al. / Journal of Cranio-Maxillo-Facial Surgery 47 (2019) 902e908 others were retrospective studies. 789 patients were evaluated: 2013), Wardill-Kilner (Johnston et al., 2004), two flap (Ganesh et al., 755 with complete unilateral cleft lip and palate; 12 with complete 2015; Liao et al., 2014), Sommerlad (Xu et al., 2015), bone graft bilateral cleft lip and palate; and 22 with incomplete unilateral cleft (Friede and Enemark, 2001), pushback (Tanino et al., 1997; lip. No evaluated patient had any associated syndrome (Tables 1 Melissaratou and Friede, 2002), and single flap from the non-cleft and 2). side (Rossell-Perry, 2018). One study (Fudalej et al., 2012) did not report the gender of the patients in one of the evaluated groups, while another study 3.3. Risk of bias/quality analysis of the included studies (Tanino et al., 1997) did not report the gender of any of the included patients. In all, 451 male and 253 female patients were identified.