Clinical trial NCT02574117: Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion
Official title: Corticotomy-assisted Slow Maxillary Expansion With Bone Allograft Assessed With Cone Beam Computed Tomography in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Cross Bite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Maxillary expansion was performed for adult female patients suffering from maxillary constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and activated at the day of corticotomy and bone graft. The activation was made half-molar unit each side. The patient was scheduled each month to activate the appliance or reactivate if needed. Corticotomy was performed at area of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was performed, before appliance activation and corticotomy, at the end of expansion (8 months) and after finishing orthodontic treatment (average 2.5 years from start of treatment).

Detailed description: Maxillary expansion was performed for adult female patients suffering from maxillary constriction with bilateral posterior cross-bite \& dental arch discrepancy average 12 mm using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and activated at the day of corticotomy and bone graft (demineralized freeze-dried bone allograft). The activation was made half-molar unit each side. The patient was scheduled each month to activate the appliance or reactivate if needed. Corticotomy was performed at area of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was performed at three stages.

T1 (baseline) Before appliance activation and corticotomy. T2 At the end of expansion. (about 8 months of expansion). T3 At the finishing stage of orthodontic treatment (average 2.5 years from start of treatment).

Eligibility criteria: Inclusion Criteria:

* Adult female patients (18-22 years) suffering from maxillary constriction with bilateral posterior cross-bite.
* Dental arch discrepancy average 12 mm.

Exclusion Criteria:

* Having any given systemic disease.
* Taking any type of medication and/or antibiotic therapy during the 3 months before the study.
* Didn't perform previous orthodontic treatment.
* Current or former smokers.

Primary outcomes:
measure: Inter-arch distance
timeFrame: Change in mm from baseline before surgical procedure to first follow up at 8 months. Change in mm from first follow up at 8 months to second follow up after 2.5 years. Change in mm from baseline to second follow up after 2.5 years.
Secondary outcomes:
measure: Change in tipping angle.
timeFrame: Change from baseline before surgical procedure to first follow up at 8 months. Change from first follow up at 8 months to second follow up after 2.5 years. Change from baseline to second follow up after 2.5 years.
measure: Degree of cross bite assessed by measuring mm distance between buccal cusp of the tooth in the upper arch and buccal cusp of same tooth in lower arch.
timeFrame: Change from baseline before surgical procedure to first follow up at 8 months. Change from first follow up at 8 months to second follow up after 2.5 years. Change from baseline to second follow up after 2.5 years.
measure: Dehiscence score.
timeFrame: Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years.
measure: Buccal bone thickness.
timeFrame: First follow up at 8 months. Second follow up after 2.5 years.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine, Cairo University
Study officials:
affiliation: Associate Professor of Oral and Maxillofacial radiology, Faculty of Oral and Dental Medicine, Cairo University.
name: Mohammed Khalifa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Orthodontics, Faculty of Oral and Dental Medicine, Cairo University.
name: Eman Mohii, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
name: Noha Ghallab, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hassan AH, Al-Saeed SH, Al-Maghlouth BA, Bahammam MA, Linjawi AI, El-Bialy TH. Corticotomy-assisted orthodontic treatment. A systematic review of the biological basis and clinical effectiveness. Saudi Med J. 2015 Jul;36(7):794-801. doi: 10.15537/smj.2015.7.12437.
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citation: Hassan AH, AlGhamdi AT, Al-Fraidi AA, Al-Hubail A, Hajrassy MK. Unilateral cross bite treated by corticotomy-assisted expansion: two case reports. Head Face Med. 2010 May 19;6:6. doi: 10.1186/1746-160X-6-6.