Results of Randomized Controlled Trial of Soft Palate First Versus Hard Palate First Repair in Unilateral Complete Cleft Lip and Palate

Author(s):  
Bruce Richard ◽  
Joyce Russell ◽  
Siobhan McMahon ◽  
Ron Pigott
2019 ◽  
Vol 57 (4) ◽  
pp. 420-429
Author(s):  
Susanna Botticelli ◽  
Annelise Küseler ◽  
Kirsten Mølsted ◽  
Helene Soegaard Andersen ◽  
Maria Boers ◽  
...  

Aim: To examine the association of cleft severity at infancy and velopharyngeal competence in preschool children with unilateral cleft lip and palate operated with early or delayed hard palate repair. Design: Subgroup analysis within a multicenter randomized controlled trial of primary surgery (Scandcleft). Setting: Tertiary health care. One surgical center. Patients and Methods: One hundred twenty-five infants received cheilo-rhinoplasty and soft palate repair at age 3 to 4 months and were randomized to hard palate closure at age 12 or 36 months. Cleft size and cleft morphology were measured 3 dimensionally on digital models, obtained by laser surface scanning of preoperative plaster models (mean age: 1.8 months). Main outcome measurements: Velopharyngeal competence (VPC) and hypernasality assessed from a naming test (VPC-Sum) and connected speech (VPC-Rate). In both scales, higher scores indicated a more severe velopharyngeal insufficiency. Results: No difference between surgical groups was shown. A low positive correlation was found between posterior cleft width and VPC-Rate (Spearman = .23; P = .025). The role of the covariate “cleft size at tuberosity level” was confirmed in an ordinal logistic regression model (odds ratio [OR] = 1.17; 95% confidence interval [CI]:1.01-1.35). A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = −.27; P = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99). Conclusions: Posterior cleft dimensions can be a modest indicator for the prognosis of velopharyngeal function at age 5 years, when the soft palate is closed first, independently on the timing of hard palate repair. Antero-posterior palatal length seems to protect from velopharyngeal insufficiency and hypernasality. However, the association found was significant but low.


2006 ◽  
Vol 43 (3) ◽  
pp. 329-338 ◽  
Author(s):  
Bruce Richard ◽  
Joyce Russell ◽  
Siobhan McMahon ◽  
Ron Pigott

Objective To compare the outcomes for primary repair of unilateral cleft lip and palate, operating on the soft palate first versus the hard palate first. Design Randomized controlled trial. Setting The Regional Cleft Service of West Nepal. Patients Forty-seven consecutive patients with nonsyndromic unilateral cleft lip and palate, of whom 37 were assessed 4 to 6 years after completing primary surgical repair. Interventions Primary repair of unilateral cleft lip and palate by two differing sequences: (1) soft palate repair, with hard palate and lip repair 3 months later; and (2) lip and hard palate repair, followed by the soft palate repair 3 months later. Main Outcome Measures Analysis of dental study models, weight gain, and speech recordings. Results Four to 7 years after completing the cleft closure, there was no significant difference in facial growth between the two types of repair sequencing. Completing posterior repair first had no effect on anterior alveolar gap width. It narrowed the hard palate gap by reducing the intercanine distance. Anterior repair dramatically closed the anterior alveolar gap, and narrowed the intercanine distance. Comparing anterior alveolar gap width with age at first presentation demonstrated that there was no spontaneous narrowing of the cleft in older children. Completing posterior closure first had a weight gain advantage over anterior closure first. Improved oropharyngeal closure, and thus swallowing, is the likely explanation. Conclusion Changing the sequencing of cleft closure has no demonstrable difference in facial growth at 4 to 7 years after completion of the primary surgery.


2020 ◽  
Vol 57 (12) ◽  
pp. 1382-1391
Author(s):  
Mohamed Abd El-Ghafour ◽  
Mamdouh A. Aboulhassan ◽  
Amr Ragab El-Beialy ◽  
Mona M. Salah Fayed ◽  
Faten Hussein Kamel Eid ◽  
...  

Objective: The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. Design: A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial. Setting: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. Participants: Thirty-one, nonsyndromic infants with UCLP. Interventions: The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop scanner producing digital models for outcome assessment. Main Outcomes Measures: A blinded assessor carried out all the MAD measurements virtually on the produced digital models at the beginning (T1) and after (T2) treatment. Results: Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group. Conclusions: It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.


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