|- candidate number||2801|
|- NTR Number||NTR1087|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-okt-2007|
|- Secondary IDs||233.359/2003/206 MEC Rotterdam|
|- Public Title||Maxillary transverse expansion; surgical and orthodontic aspects.|
|- Scientific Title||Maxillary transverse expansion; surgical and orthodontic aspects.
|- hypothesis||In skeletally matured, non-syndromal patients with transverse maxillary hypoplasia, increased stability in transverse dimensions at tooth and bone levels, less dental complications, and a better end-result is achieved with a TPD device compared to a Hyrax expander. |
|- Healt Condition(s) or Problem(s) studied||Transverse maxillary hypoplasia|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2004|
|- planned closingdate||1-jan-2008|
|- Target number of participants||40|
|- 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.
|- Primary outcome||Relapse of the maxilla in transverse dimension. |
|- Secondary outcome||Nasal volume / flow measurements and subjective improvement of nasal breathing.|
|- Timepoints||1. Pre-operative;|
3. 1 year post operative.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| M.J. Koudstaal|
|- CONTACT for SCIENTIFIC QUERIES|| M.J. Koudstaal|
|- Sponsor/Initiator ||Erasmus Medical Center, Department Oral and Maxillofacial Surgery|
(Source(s) of Monetary or Material Support)
|Erasmus M.C. Department of Oral and Maxillofacial Surgery|
|- Publications||1. Surgical Assisted Rapid Maxillary Expansion (SARME); a review of the literature
Int. J. Oral Maxillofac. Surg. 2005; 34:709-714;|
2. Experiences with the Transpalatal distractor in congenital deformities
Mund Kiefer Gesichtchirurgie 2006;10(5):331-334;
3. The Rotterdam Palatal Distractor; introduction of the new bone-borne device and report of the pilot study
Int. J. Oral Maxillofac. Surg. 2006;35:31-35;
4. Distractie osteogenese in het hoofd-hals gebied
Ned Tijdschr van Geneeskunde 2006, 28, 1557-1561(in Dutch);
5. Surgical assisted rapid maxillary expansion in two cases of osteopathia striata with cranial sclerosis CPCS Journal, accepted.
|- Brief summary||In patients with transverse and sagittal maxillary hypoplasia of the midface, buccal cross bites (unilateral and bilateral), anterior and posterior crowding, dental compensation such as lingual tipping of mandibular posterior teeth, and buccal corridors can be noticed clinically. Orthodontic correction of the transverse discrepancy is successful until closure of the midpalatal suture at approximately 14-15 years of age depending on the gender of the patient (Profitt, 2000, Melsen, 1975). Once skeletal maturity has been reached, Surgically Assisted Rapid Maxillary Expansion (SARME) in combination with a corticotomy must be performed in order to release the areas of bony resistance such as the midpalatal suture, the zygomatic buttresses, and the piriform aperture. This technique includes a buccal corticotomy and a median osteotomy. It appears predictable, and a sufficient amount of expansion as well as long-term stable results can be obtained. There are several advantages: bone apposition in the osteotomy sites, reduced risk of dental version or extrusion compared to regular orthopaedic care, and increased periodontal stability. Finally, transverse occlusal stability results in stable sagittal and vertical relationships.
Traditionally, a tooth-borne orthodontic appliance called a hyrax expander is placed preoperatively to expand the maxilla (Figure 1, Hyrac CE 0297, Forestadent, Pforzheim, Germany). It is suggested that dental anchorage gives rise to several com-plications: damage to the teeth, possible loss of anchorage, periodontal membrane compression and buccal root resorption, cortical fenestration, skeletal relapse, anchor-age-tooth tipping and segmental tipping, instead of parallel expansion (Profitt, 2000, Mommaerts, 1999). Advantages of the hyrax expander are the fact that it can be pla-ced and removed in the orthodontic outpatient clinic without local anesthesia. Fur-thermore the hyrax expander is less expensive than the bone-borne devices.|
To avoid the dental complications bone-borne devices, such as the Transpalatal Distractor (TPD, CE 9001, Surgi-tec, Bruges, Belgium) was developed in 1999 (Mom-maerts, 1999) and the Rotterdam Palatal Distractor (RPD, KLS Martin, Postfach 60, D-78501 Tuttlingen, Germany) were designed.
Aim of the study: The aim of this study is to evaluate two conventional distraction modes, the tooth-borne versus the bone-borne in a group of skeletally matured non-syndromal patients with transverse maxillary hypoplasia.
Hypothesis: In skeletally matured, non-syndromal patients with transverse maxillary hy-poplasia, increased stability in transverse dimensions at tooth and bone levels, less dental complications, and a better end-result is achieved with a bone-borne devices compared to a tooth-borne expander.
Randomization: The patients are randomized in either the tooth-borne or bone-borne group.
|- Main changes (audit trail)|
|- RECORD||10-okt-2007 - 20-mrt-2008|