On behalf of the Institute for Quality and Efficiency in Health Care (IQWiG), a working group of the Hannover Medical School (MHH) has studied the treatment outcomes in case of nasoalveolar molding (NAM) for cleft lip and palate. The report was published in February 2019.
There is no generally accepted treatment concept for cleft lip and palate. Usually the lip and palate defects are surgically closed at the age of about three to six months. NAM is an individually made nonsurgical method of reshaping the gums, lip and nostrils in order to improve the conditions for the further surgery. If the NAM is successful, further surgical intervention may be avoided.
A systematic literature search for primary literature sources was carried out in the databases MEDLINE, Embase and Cochrane Central Register of Controlled Trials. In parallel, a search for relevant systematic reviews was carried out in the databases MEDLINE, Embase, Cochrane Database of Systematic Reviews and HTA Database. Four prospective non-randomized controlled trials were identified as relevant to the issue of benefit assessment. In addition, 2 ongoing randomized controlled trials were identified.
Results:
- Results on anthropometric parameters of the nasal region were available in three studies, with only one of them presenting both medium-term (3-month, 1-year) and long-term (>6 years) outcomes. In all studies, a significant difference between the NAM versus no-NAM study groups was identified (e.g., for the length of the right and left columellae, for nasal tip protrusion, for the alveolar gap, and for the cleft lip segment). Due to insufficient information on results and different follow-ups, no meta-analysis was performed in the information synthesis
- Facial appearance results were only measured in one study. However, there were no primary data in the publication, only illustrations, and body text. The degree of deviation after palatal surgery was similar in the two groups and significantly lower in NAM. Change in the degree of deviation from the initial value to palatal surgery was higher in NAM
- In all studies, only data on the "facial aesthetics" outcome (including symmetry, facial expressions, anthropometric parameters) were reported. Mortality, morbidity, and function (including respiration, nutrition, hearing, speech, dental and jaw position), social and emotional development, adverse events (including pain, scars), number and operations duration or hospital stays, and health-related quality of life of affected individuals were not reported in any study. The bias potential of the results for all outcomes was rated as high for all studies
Therefore, it was concluded, that there are no clinical studies up to date with high reliability statements on the benefits and harms of the NAM. Consequently, the working group of the MHH stated, that considerable research is needed and called for studies with high reliability. The final report will be finalized and all the documents will be published on the ThemenCheck Medizin and forwarded to the Federal Joint Committee (G-BA) and the Federal Ministry of Health (BMG).
The full details in German can be found here.
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