Evaluation of the Clinical Effectiveness of Nasoalveolar Molding (NAM) Using Grayson Method Versus Computer-Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

Abstract

Objective:

The aim is to compare between the clinical effectiveness of nasoalveolar molding (NAM) versus the computer-aided design NAM (CAD/NAM) in patients with bilateral clefts.

Design:

The trial is a randomized comparative trial with 1:1 allocation ratio.

Participants:

Thirty infants with bilateral complete cleft lip and palate were recruited.

Interventions:

Patients were randomized between NAM and CAD/NAM groups. The treatment steps described by Grayson were followed for the NAM group. In the CAD/NAM group, digitized maxillary models were made to create series of modified virtual models which were used to fabricate the molding plates using 3-dimensional printing technology. The nasal stents were then added to the plates following Grayson method. The study lasted for 4 months.

Main Outcomes:

The primary outcome was to evaluate the changes in the intersegment cleft gap. Secondary outcomes included the analysis of the maxillary arch in transverse, anteroposterior, and vertical dimensions as well as the premaxillary deviation and rotation. Chair side time was assessed for both methods.

Results:

Both modalities decreased the intersegment cleft gap. The CAD/NAM plates caused more reduction in the total arch length by 1.99 mm (−3.79 to 0.19, P = .03) as compared to the NAM treatment. No differences were found between groups in the transverse and vertical maxillary arch changes.

Conclusions:

Both interventions were effective in narrowing the cleft gap. Similar maxillary changes were found in both groups. The CAD/NAM modality required less chair side time compared to the NAM treatment.

Keywords

bilateral clefts infant orthopedics maxillary arch

Get full access to this article

View all access options for this article.

References

Batra

Gribel

Abhinav

Arora

Raghavan

. OrthoAligner “NAM”. A case series of presurgical infant orthopedics (PSIO) using clear aligners. Cleft Palate-Craniofacial J. 2020;57(5):646–655.

Bauer

Schönberger

Gattinger

Eblenkamp

Wintermantel

Rau

Güll

Wolff

Loeffelbein

. RapidNAM. Generative manufacturing approach of nasoalveolar molding devices for presurgical cleft lip and palate treatment. BiomedTech. 2017;62(4):407–414.

Chou

Hallac

Ajiwe

Xie

Liao

Kane

Park

. The role of Nasoalveolar molding: a 3D prospective analysis. Sci Rep. 2017;7(1):1–8.

Cutting

Grayson

Brecht

Santiago

Wood

Kown

. Presurgical collumellar elongation and primary retrograde nasal reconstruction in one-stage bilateral cleft lip and nose repair. Plast Reconstr Surg. 1998;101(3):630–639.

Dürwald

Dannhauer

K-H

. Vertical development of the cleft segments in infants with bilateral cleft lip and palate. J Orofac Orthop. 2007;68(3):183–197.

Garfinkle

King

Grayson

Brecht

Cutting

. A 12-year anthropometric evaluation of the nose in bilateral cleft lip-cleft palate patients following nasoalveolar molding and cutting bilateral cleft lip and nose reconstruction. Plast Reconstr Surg. 2011;127(4):1659–1667.

Gong

. Correction of maxillary deformity in infants with bilateral cleft lip and palate using computer-assisted design. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012;114(5 suppl):S74–S78.

Gong

Zhao

Zheng

. A digital assessment of the maxillary deformity correction in infants with bilateral cleft lip and palate using computer-aided nasoalveolar molding. J Craniofac Surg. 2017;28(6):1543–1558.

Grayson

Cutting

Wood

. Preoperative columella lengthening in bilateral cleft lip and palate. Plast Reconstr Surg. 1993;92(7):1422–1423.

10.

Grayson

Santiago

Brecht

Cutting

. Presurgical nasoalveolar molding in infants with cleft lip and palate. Cleft Palate-Craniofac J. 1999;36(6):486–498.

11.

Grill

Ritschl

Dikel

Rau

Roth

Eblenkamp

Grill

Wolff

Loeffelbein

Bauer

. Facilitating CAD/CAM nasoalveolar molding therapy with a novel click-in system for nasal stents ensuring a quick and user-friendly chairside nasal stent exchange. Sci Rep. 2018;8(1):12084.

12.

Hak

Sasaguri

Sulaiman

Hardono

Suzuki

Nakamura

Ohishi

. Longitudinal study of effect of hotz’s plate and lip adhesion on maxillary growth in bilateral cleft lip and palate patients. Cleft Palate-Craniofacial J. 2012;49(2):230–236.

13.

Kuijpers

MAR

Chiu

Y-T

Nada

Carels

CEL

Fudalej

. Three-dimensional Imaging methods for quantitative analysis of facial soft tissues and skeletal morphology in patients with orofacial clefts: a systematic review. PLoS One. 2014;9(4):e93442.

14.

Latham

RA.

Bilateral cleft lip and palate: improved maxillary and dental development. Plast Reconstr Surg. 2007;119(1):287–297.

15.

Lee

CTH

Garfinkle

Warren

Brecht

Cutting

Grayson

. Nasoalveolar molding improves appearance of children with bilateral cleft lip-cleft palate. Plast Reconstr Surg. 2008;122(4):1131–1137.

16.

Liao

Wang

Chen

Pai

Wang

. Comparative outcomes of two nasoalveolar molding techniques for bilateral cleft nose deformity. Plast Reconstr Surg 2014;133(1):103–110.

17.

Loeffelbein

Ritschl

Rau

Wolff

K-D

Barbarino

Pfeifer

Schönberger

Wintermantel

. Analysis of computer-aided techniques for virtual planning in nasoalveolar moulding. Br J Oral Maxillofac Surg. 2015;53(5):455–460.

18.

Mishima

Sugahara

Mori

Minami

Sakuda

. Effects of presurgical orthopedic treatment in infants with complete bilateral cleft lip and palate. Cleft Palate Craniofac J. 1998;35(3):227–232.

19.

Moher

Hopewell

Schulz

Montori

Gøtzsche

Devereaux

, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.

20.

Mulliken

. Principles and techniques of bilateral complete cleft lip repair. Plastic Reconstr Surg. 1985;75(4):477–487.

21.

Oosterkamp

BCM

van der Meer

Rutenfrans

Dijkstra

. Reliability of linear measurements on a virtual bilateral cleft lip and palate model. Cleft Palate Craniofac J. 2006;43(5):519–523.

22.

Oosterkamp

BCM

van Oort

Dijkstra

Stellingsma

Bierman

MWJ

de Bont

LGM

. Effect of an intraoral retrusion plate on maxillary arch dimensions in complete bilateral cleft lip and palate patients. Cleft Palate Craniofacial J. 2005;42(3):239–244.

23.

Patel

Rubin

Clouston

Lalezaradeh

Brecht

Cutting

Shetye

Warren

Grayson

. Comparative study of early secondary nasal revisions and costs in patients with clefts treated with and without nasoalveolar molding. J Craniofac Surg. 2015;26(4):1229–1233.

24.

Ritschl

Rau

Gull

diBora

Wolff

K-D

Schonberger

Bauer

Wintermantel

Loeffelbein

. Pitfalls and solutions in virtual design of nasoalveolar molding plates by using CAD/CAM technology-A preliminary clinical study. J Craniomaxillofac Surg. 2016;44(4):453–459.

25.

Rosti

Sfondrini

Bressani

Vitale

Gandini

Scribante

. Digital workflow for indirect bonding with 2D lingual brackets: A case report and procedure description. Case Rep Dent. 2019;1–6.

26.

Rubin

Clouston

Ahmed

M Lowe

Shetye

Broder

Warren

Grayson

. Assessment of presurgical clefts and predicted surgical outcome in patients treated with and without nasoalveolar molding. J Craniofac Surg. 2015;26(1):71–75.

27.

Shaw

. Global strategies to reduce the health care burden of craniofacial anomalies: Report of WHO meetings on International Collaborative Research on Craniofacial Anomalies. Cleft Palate-Craniofacial J. 2004;41(3):238–243.

28.

Shen

Yao

Magee

Chai

Zhang

. Presurgical nasoalveolar molding for cleft lip and palate: the application of digitally designed molds. Plast Reconstr Surg. 2015;135(6):1007e–1015e.

29.

Singer

Daskalogiannakis

Russell

Mercado

Hathaway

Stoutland

Long

Jr Fessler

Semb

Shaw

. Burden of care of various infant orthopedic protocols for improvement of nasolabial esthetics in patients with CUCLP. Cleft Palate-Craniofacial J. 2018;55(9):1236–1243.

30.

Spengler

Chavarria

Teichgraeber

Gateno

Xia

. Presurgical nasoalveolar molding therapy for the treatment of bilateral cleft lip and palate: a preliminary study. Cleft Palate Craniofac J. 2006;43(3):321–328.

31.

Suri

Disthaporn

Atenafu

Fisher

. Presurgical presentation of columellar features, nostril anatomy, and alveolar alignment in bilateral cleft lip and palate after infant orthopedics with and without nasoalveolar molding. Cleft Palate-Craniofacial J. 2012;49(3):314–324.

32.

Gong

Shen

. CAD presurgical nasoalveolar molding effects on the maxillary morphology in infants with UCLP. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013;116(4):418–426.

33.

Gong

Wang

G-M

Z-Y

Qian

Y-F

Shen

. A novel technique for presurgical nasoalveolar molding using computer-aided reverse engineering and rapid prototyping. J Craniofac Surg. 2011;22(1):142–146.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.24 MB