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Maxillary transverse expansion; surgical and orthodontic aspects.

Maxillary transverse expansion; surgical and orthodontic aspects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28139
Enrollment
40
Registered
2007-10-10
Start date
2004-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transverse maxillary hypoplasia in skeletally matured non-syndromal patients. Dutch: transversale maxilaire hypoplasie bij skeletaal-volwassen non-syndromatische.

Interventions

Randomization into two groups after standard surgery for widening the narrow maxilla through distraction osteogenesis: Group 1: distraction with a tooth-borne device
Group 2: distraction with a bone-borne device
The distraction phase usually lasts several weeks and the consolidation phase lasta 3 months. After this the distractor is removed.

Sponsors

Prof dr K.G.H. van der Wal Head of the Department Oral and Maxillofacial Surgery, ErasmusMC Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Non-syndromal patients, Clinically the patients can show one or more of the following situations: a. Dental cross-bite: unilateral or bilateral; b. Anterior and/or posterior crowding; c. Clinical evidence of buccal corridors (upon smiling); 2. Patients are sixteen years of age and older; 3. The transverse hypoplasia can not be corrected by orthodontics alone due to full skeletal maturation. In case of doubt about the skeletal maturity in patients between the age of sixteen and eighteen hand-wrist radiograph will be taken to determine the stage of skeletal maturation using the Greulich-Pyle analysis (Harris et al., 1980); 4. Skeletal transverse discrepancy measured on the PA-cephalogram using the Ricketts J-point analysis (Athanasiou and van der Meij, 1995); 5. The buccal osteotomy does not interfere with the apices of the dentition and there is no risk for damage to the infra-orbital nerve. This can be determined on the pre-operative panoramic x-ray as well as on the PA Cephalogram.

Exclusion criteria

Exclusion criteria: 1. Syndromal patients (including cleft); 2. Under sixteen years of age; 3. Patients skeletally not fully matured (Greulich-Pyle analysis) between the age of sixteen and eighteen; 4. History of radiation therapy in the area of interest; 5. Mental retardation.

Design outcomes

Primary

MeasureTime frame
Relapse of the maxilla in transverse dimension.

Secondary

MeasureTime frame
Nasal volume / flow measurements and subjective improvement of nasal breathing.

Contacts

Public ContactM.J. Koudstaal

‘s-Gravendijkwal 230

m.koudstaal@erasmusmc.nl+ 31 (0)10 4633302

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)