Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient (NAM)

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Unknown

Conditions

Unilateral Complete Cleft Lip

Treatments

Device: Figueroa's presurgical nasoalveolar molding
Device: Grayson's presurgical nasoalveolar molding

Study type

Interventional

Funder types

Other

Identifiers

NCT01883726
102-1267C

Details and patient eligibility

About

Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang Gung Memorial Hospital. The objective of this study is to compare the number of clinical visits, total prices, complications and nasal symmetry between these two NAM reconstruction methods.

Full description

Grayson's NAM reconstruction starts with alveolar molding first. The alveolar molding is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. After the alveolar cleft gap is less than 5 mm (usually at the end of second months), nasal molding was added to the alveolar molding plate. Figueroa's NAM reconstruction use labial tapes and acrylic relief to the palatal plate to approximate alveolar gap. The device starts with nasal and alveolar molding simultaneously.

Enrollment

30 patients

Sex

All

Ages

1 week to 3 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Complete unilateral cleft lip infant
  • Signed informed consent

Exclusion criteria

  • Incomplete unilateral cleft lip infant
  • Association of other craniofacial anomalies

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Grayson NAM
Experimental group
Description:
Intervention: Grayson nasoalveolar molding This technique uses an acrylic plate to mold the alveolar segments and uses an extension to mold the alar cartilage of the nasal component. The construction is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. When the alveolar gap is reduced to 5 mm, nasal component are added to gradually mold the nasal cartilage and other nasal structures.
Treatment:
Device: Grayson's presurgical nasoalveolar molding
Figueroa NAM
Experimental group
Description:
Intervention: Figueroa's nasoalveolar molding Figueroa technique uses labial tapes and acrylic relief to the palatal plate to approximate alveolar gap [3]. The nasal component is added in the beginning of the treatment to mold the nasal cartilage.
Treatment:
Device: Figueroa's presurgical nasoalveolar molding

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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