Nasoalveolar Moulding

The authors’ unit, which pioneered NAM in India in 2005, formulated a new NAM protocol in May 2008 ( Table 1 and Fig. 1 ). In group I NAM was continued until 6 months of age. In group II NAM was carried out for a minimum period of 3 months thereby delaying surgery up to the 8 months of age in some cases, depending on the age at presentation.

Nasoalveolar moulding appliance.

In the study group, dento-facial impressions (nasal and alveolar surface impressions) were recorded at the time of initiation of NAM (T1), on completion of NAM (T2) and at 18 months of age (T3). All impressions were recorded in the outpatient department with the patient awake and lying supine. Nasal impressions extending from the upper lip to the forehead were recorded at T1, T2 and T3 using fast setting alginate. Alveolar surface impressions were recorded at each recall visit using heavy bodied condensation silicone impression material. In the control group, nasal and alveolar surface impressions were recorded for all patients at T3. Type III dental stone was used to pour the impressions. A base was prepared for the nasal casts such that the nasal tip was at the level of the eyebrows when viewed from the basilar aspect. All nasal measurements were recorded from this position. Appliances were fabricated using autopolymerising acrylic resin. Nasal stents were made using 0.032 gauge round stainless steel wire. Soft denture liner was used to cushion the nasal stent. Heavy orthodontic elastics (red) and half inch hypoallergic surgical tapes were used to retain the plate in the infant’s mouth. Parents were advised to make the child wear the plate for 24 h a day, 7 days a week, apart from a brief period for cleaning the plate twice daily.

During each recall visit, the active participation of the parents and their ability to follow the home care instructions was assessed. The alveolus was actively moulded by selective trimming of the appliance and addition of a layer of soft liner as needed. Nasal moulding was initiated at the earliest once cleft width was <8–10 mm. Aggressive alveolar moulding was undertaken if the cleft alveolar width was >8–10 mm. Upon complete approximation of the alveolar segments, passive moulding was undertaken to retain the alveolar segments in the new improved position whilst active nasal moulding continued. All impressions, casts and NAM appliances were made by the same author (H.J.V.).

In order to blind the examiner to the group status (group I, group II or group III) and treatment stage (T1, T2 or T3) of the dental stone models, each one was assigned a randomized number. All measurements were obtained twice following a period of 1 month by the same investigator (S.M.S.). The examiner was blinded to the previously completed measurements. As some of the photographs, early on in the course of this study were found not to be standardized, dental stone models of the dento-facial impressions were used for the purpose of evaluation.

Linear anthropometric measurements as indicated by E zzat et al. for maxillary arch measurements and L iou et al. for nasal measurements were used for this study ( Table 2 and Fig. 2 ). Nasal measurements were referenced to a horizontal line which connected the most inward points at the outer lateral border of the cleft and non-cleft nostrils and were recorded for the cleft and non-cleft side. All measurements were recorded using a sliding calliper with 0.01 mm precision at T1, T2 and T3. Measurements in group III were recorded at T3.

(a) Maxillary arch and (b and c) nasal linear anthropometric measurements. ISD, intersegment distance; AW, alveolar width; NDH, nasal dome height; CH, columella height; NH, nostril height; NBW, nasal basal width; NW, nostril width.

Primary cheiloplasty was carried out for all patients on completion of presurgical nasoalveolar moulding as per the authors’ NAM protocol ( Table 1 ). All surgery was carried out by the same author (V.S.). The surgical procedure was a modified rotation–advancement cheiloplasty. The incision of the cleft margin was extended superiorly to the junction of the nasal mucosa and skin, where a release incision was given to mobilize the alar base. This was used to reconstruct the nasal floor. The orbicularis oris muscle on the cleft segment was mobilized adequately whilst that on the non-cleft segment was mobilized in all areas except underlying the philtral dimple. The lower lateral nasal cartilage on the cleft side and the columella were dissected up to the lower border of the upper lateral cartilage. Nasal septal mucosa was conservatively elevated to recreate the floor of the nose. Following muscle approximation, the alar base on the cleft side was advanced medially and superiorly. The non-cleft segment was elongated using a back-cut whilst the cleft segment was elongated using an oblique release incision. Supra white roll Z-plasty was carried out. Gingivoperiosteoplasty was not carried out for any patient. Following surgery, patients were continued with post surgical nasoalveolar moulding as per the authors’ NAM protocol ( Table 1 ).

Statistical Analysis

All data were analysed by statistical analysis package SPSS vers. 17.0 (SPSS Inc., Chicago, IL, USA). Data were analysed for intra-observer correlation using the Mann–Whitney U -test. Mean and standard deviation values were calculated for the evaluation parameters for groups I and II at T1, T2 and T3 ( Tables 3 and 4 ) and at T3 for group III ( Table 5 ). The effect of NAM on the study groups was established by determining the changes in the nasoalveolar morphology before and after completion of NAM (T1–T2). The percentage change in each group was noted. A 2 tailed unpaired t -test was used to determine the equality of mean ( Table 6 ). P < 0.05 was employed as the level of significance. Fisher’s test was used for variance analysis and Tukey’s test was used for pair wise comparison between the two cleft groups and the control group at T3 ( Table 7 ).

Table 3

Group I maxillary arch and nasal linear measurements at T1, T2 and T3.

		T1		T2		T3
Measurements	Side	Mean	SD	Mean	SD	Mean	SD
Intersegment distance		12.4	3.9835	2.3	1.9552	2.207	2.8776
Alveolar width		42.027	10.769	43.0	10.2688	44.007	10.0827
Nasal basal width	C	17.507	1.8219	14.273	1.9159	12.979	2.3606
	NC	7.24	1.4312	10.087	1.6907	13.127	2.1137
Nostril width	C	14.9	2.5612	11.95	2.94	8.69	2.72
	NC	4.5	1.6427	6.04	1.86	9.28	4.68
Nostril height	C	2.513	0.8236	6.42	1.2835	7.687	2.4643
	NC	6.027	1.4185	8.36	1.4441	8.807	2.2626
Nasal dome height	C	7.48	1.6297	12.187	1.7699	14.747	3.4523
	NC	10.727	1.4089	13.28	1.6196	15.773	2.5839
Columella height	C	0.927	0.6573	2.633	0.5888	2.46	0.6231
	NC	3.093	0.5444	3.593	0.3654	3.087	0.6424

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