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Title The Use of Pre-Surgical Nasoalveolar Molding (PNAM) in Unilateral Cleft Lip and Palate Patients Reduces Width of Alveolar Cleft
Clinical Question In patients with unilateral cleft lip and palate, does the use of pre-surgical nasoalveolar molding (PNAM) therapy reduce the width of the alveolar cleft?
Clinical Bottom Line The use of pre-surgical nasoalveolar molding in unilateral cleft lip and palate patients reduces the alveolar cleft width. This is supported by a randomized controlled trial including 120 patients (60 controls) and a case control study with 30 patients. All patients studied were previously diagnosed with unilateral cleft lip and palate and were shown to have a significant reduction in intersegmental distances (alveolar gap width) after being subjected to PNAM therapy.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 28416097Shetty/201760 nonsyndromic complete UCLP patients in whom PNAM was used, control = 60 nonsyndromic complete UCLP patients in whom PNAM was NOT usedRandomized Controlled Trial
Key resultsThe effects of PNAM were studied in this randomized controlled trial. One hundred twenty unilateral cleft lip and palate (UCLP) patients were included in the study group and divided into two groups: 60 patients subjected to PNAM therapy and 60 patients not subjected to PNAM therapy (control). Study patients were divided into three groups: T1 defined as first visit when PNAM was initiated, T2 defined as completion of PNAM therapy, and T3 defined as 6 years of age. Control patients were also divided into three groups: T1 defined as first visit, T2 defined as before cheiloplasty surgery, and T3 defined as 6 years old. From T1 to T2, the study group had significant reduction in the intersegmental distance (8.40 mm) and the control group had a slight increase. At T2 (completion of PNAM therapy for study group), the mean ISD for the study group (5.38 mm) was significantly less than that of the control (14.13 mm). When comparing the study to the control, the mean difference between T1 and T2 was statistically significant (P<0.001).
#2) 28317355Hongyi/201630 UCLP patients who were treated with PNAMCase Control Study
Key resultsThis study included 30 patients with complete unilateral cleft lip and palate. Maxillary impressions were taken before and after PNAM therapy, scanned using CBCT, and made into 3D study models. This study shows that following PNAM treatment, the alveolar cleft decreased considerably (P<0.05), correcting the alveolar malformation.
Evidence Search PNAM[All Fields] AND alveolar[All Fields] AND cleft[All Fields]
Comments on
The Evidence
Validity: In Shetty/2017, written informed consent was obtained from guardians before the patients were included in the trial. There was no funding, no competing interests, and adequate patient follow up was conducted (6 years of age). An independent examiner obtained all results from stone casts using a calibrated caliper, and the examiner was blinded to subgroup status. In Hongyi/2016, all patients received the same therapy. The study had adequate follow up to the conclusion of PNAM therapy. It is unclear if there was recall bias; however, it is unlikely due to no reliance on patient memory. The results were based on measurements made from study models using software. It is unclear if there were competing interests. Perspective: Based on the evidence, it is reasonable to conclude that PNAM therapy does, in fact, reduce the alveolar gap width in unilateral cleft lip and palate patients. PNAM is a beneficial therapy in correcting alveolar deformity and improving appearance of cleft lip and palate patients.
Applicability Cleft lip and palate is a common craniofacial anomaly in pediatric dentistry. The pre-surgical nasoalveolar molding therapy is feasible in a pediatric dental residency or private practice pediatric dental office, and the results prove that PNAM therapy can reduce the intersegmental distance prior to surgery for unilateral cleft lip and palate patients. PNAM therapy provides a treatment to correct alveolar irregularity.
Specialty/Discipline (Oral Surgery) (Pediatric Dentistry)
Keywords Complete unilateral cleft lip and palate, presurgical nasoalveolar molding, cleft lip and palate therapy
ID# 3327
Date of submission: 09/05/2018spacer
E-mail ardoinh@livemail.uthscsa.edu
Author Holly Ardoin
Co-author(s) e-mail
Faculty mentor/Co-author Jungyi Alexis Liu
Faculty mentor/Co-author e-mail LiuJA@uthscsa.edu
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