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Title Pre-Surgical Infant Orthopedics (PSIO) And Naso-Alveolar Molding (NAM) Show Promise For Obtaining Normal Anatomy Of The Nose And Lip In Patients With Cleft Lip And Palate
Clinical Question In a child with cleft lip and palate, is there long-term benefit to pre-surgical naso-alveolar molding versus traditional surgical treatment alone?
Clinical Bottom Line Long-term anthropologic studies comparing NAM to traditional treatment show equivocal results; however, pre-surgical infant orthopedics (PSIO) is gaining a body of literature to support it’s use.
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) 20858135Uzel/20117 RCT’s min 6 year follow/upSystematic Review
Key resultsOutcomes included maternal satisfaction, feeding, speech, facial growth, occlusion, maxillary arch, and facial esthetics. Only facial esthetics showed mild benefit. Patients with Unilateral Cleft Lip and Palate (UCLP) showed mild improvements that tended to disappear as the patient got older.
#2) 21460673Garfinkle/201177 non-syndromic patients with BCLPCohort study
Key resultsUsing nasal casts and a digital calipers, the following parameters were measured at 5 points in time over 12.5 years: nasal tip protrusion, alar base width, alar width, columella length, and columella width. By the 5th measurement, the differences between the cleft and non-cleft patients were not significant (p> 0.05), suggesting that the BCLP patients in this study were anthropologically normal compared to non-cleft patients.
#3) 21239929Clark/201125 UCLP patients 20 received PNAM 5 non-PNAM Cohort Study
Key resultsPatients with UCLP were treated with either NAM or non-NAM therapy. The NAM group showed significant improvement (95% achieved normal vermillion vs. only 20% non-NAM). However, the 3D analysis did not produce significant differences.
Evidence Search (("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 nasoalveolar[All Fields]) AND (English[lang]
Comments on
The Evidence
Weak evidence is present to support the statement that NAM/PSIO will provide a normal columella and alar anatomy as compared to children without CLP or children with CLP or who obtained traditional surgical treatment alone. This treatment modality has results that must be measured for long periods of time and the ethical dilemmas with obtaining a control makes studying outcomes difficult. Furthermore, a definitive treatment protocol for PSIO as well as surgical protocols are different in many of the studies on this topic. Therefore, adequate comparisons are often difficult to find. Unfortunately, at this time there is not a good body of evidence to support a statement either for or against using PSIO. However, a trend in the newer literature is being seen to support its use.
Applicability This treatment is applicable to children with Cleft Lip and Palate or providers who are part of cleft teams and are looking to either expand their treatment modalities or support use of NAM/PSIO.
Specialty/Discipline (Public Health) (General Dentistry) (Oral Surgery) (Orthodontics) (Pediatric Dentistry) (Prosthodontics)
Keywords PSIO, PNAM, NAM, Cleft lip, Cleft palate, Alveolar molding, nasoalveolar molding
ID# 2163
Date of submission: 10/08/2011spacer
E-mail sheridanr@uthscsa.edu
Author Ryan Sheridan, DDS, MS
Co-author(s) e-mail
Faculty mentor/Co-author Anthony Sallustio, DDS
Faculty mentor/Co-author e-mail
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
post a rationale
None available
Comments and Evidence-Based Updates on the CAT
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by Su Jin Lim, Laura Aguilar (San Antonio, TX) on 12/01/2017
A PubMed search for newer evidence was performed in November 2017. A case study done by Shen in June 2015 (PMID 26017607) concluded that presurgical nasoalveolar molding for infant patients with cleft lip and palate showed equivalent results to those of traditional cleft lip and palate treatments. A nonrandomized, prospective, multicenter study (PMID 26910677) done by Broder in March 2016 also concluded that infants who received nasoalveolar molding treatments showed similar results to those who were subject to traditional treatment alone. These recent studies did not significantly change the conclusion of this CAT. A retrospective study published by Fuchigami in November 2017 (PMID 28921849) stated that pre-surgical nasoalveolar moldings on infants with unilateral cleft lips and palates enhanced symmetry in the maxillary alveolar arch and nasolabial form. The study supported the answer of the clinical question, showing that pre-surgical orthopedic treatments are increasingly gaining support.

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