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CompletedNCT02574117Updated Apr 7, 2016

Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

An interventional study of flap with corticotomy and bone allograft in Posterior Cross Bite, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 22 Years
Sex
Female
01

Study 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).

Read the 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).

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Conditions studied

  • Posterior Cross Bite

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In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 4 is below the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 22 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    flap with corticotomy and bone allograft

    Maxillary expansion with quad helix appliance was applied to posterior teeth with cross bite. Then corticotomy surgical procedure associated with addition of commercially available bone allograft; demineralized freeze-dried bone allograft on the buccal surface of maxillary 1st premolar, 2nd premolar and 1st molar areas.

    Procedure: flap with corticotomy and bone allograft

Interventions

  • Procedureflap with corticotomy and bone allograft

    A maxillary expansion with quad helix appliance was placed on the posterior teeth with cross bite. A Luebke buccal flap was opened in the area of maxillary 1st premolar, 2nd premolar and first molar with a no. 15 scalpel. Corticotomy procedure was performed using low speed round bur size 3, holes to create a 0.5 mm deep hole penetrating the cortical bone. Multiple holes were performed leaving 1.5 mm distance in between. The defects were covered with demineralized freeze-dried bone allograft and the flap was sutured in its original position with 3-0 black silk suture.

    Also known as: periodontally accelerated orthodontics and DFDBA

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What researchers measure

Primary outcomes

  1. Inter-arch distance

    Change in mm inter arch distance from baseline before appliance activation and corticotomy till first follow up 8 months after expansion. Change in mm inter-arch distance from first follow up 8 months after expansion till second follow up 2.5 years from start of treatment after finishing orthodontic treatment. Change in mm inter-arch distance from baseline before appliance activation and corticotomy till second follow up 2.5 years from start of treatment after finishing orthodontic treatment.

    Time frame: 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

  1. Change in tipping angle.

    Change in tipping angle from baseline before appliance activation and corticotomy till first follow up 8 months after expansion. Change in tipping angle from first follow up 8 months after expansion till second follow up 2.5 years from start of treatment after finishing orthodontic treatment. Change in tipping angle from baseline before appliance activation and corticotomy till second follow up 2.5 years from start of treatment after finishing orthodontic treatment.

    Time frame: 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.

  2. 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.

    Change in degree of cross bite from baseline before appliance activation and corticotomy till first follow up 8 months after expansion. Change in degree of cross bite from first follow up 8 months after expansion till second follow up 2.5 years from start of treatment after finishing orthodontic treatment. Change in degree of cross bite from baseline before appliance activation and corticotomy till second follow up 2.5 years from start of treatment after finishing orthodontic treatment.

    Time frame: 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.

  3. Dehiscence score.

    Dehiscence is the amount of buccal alveolar bone loss around the root surface. Dehiscence score as follows; score 0: No Dehiscence. score 1: Dehiscence in cervical third of root only. score 2: Dehiscence in cervical third and middle third of root surface only. score 3: Dehiscence in cervical third and middle third and apical third of root surface. Dehiscence is assessed at first follow up 8 months after expansion and at the second follow up 2.5 years from start of treatment after finishing orthodontic treatment.

    Time frame: Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years.

  4. Buccal bone thickness.

    Assessment of the Buccal bone thickness at first follow up 8 months after expansion and at second follow up 2.5 years from start of treatment after finishing orthodontic treatment.

    Time frame: First follow up at 8 months. Second follow up after 2.5 years.

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Study locations

1 site
  • Faculty of Oral and Dental Medicine, Cairo University
    Cairo, Egypt
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References and documents

Publications

  • Cano J, Campo J, Bonilla E, Colmenero C. Corticotomy-assisted orthodontics. J Clin Exp Dent. 2012 Feb 1;4(1):e54-9. doi: 10.4317/jced.50642. eCollection 2012 Feb. PubMed 24558526 ↗
  • Shoreibah EA, Ibrahim SA, Attia MS, Diab MM. Clinical and radiographic evaluation of bone grafting in corticotomy-facilitated orthodontics in adults. J Int Acad Periodontol. 2012 Oct;14(4):105-13. PubMed 23210199 ↗
  • Shoreibah EA, Salama AE, Attia MS, Abu-Seida SM. Corticotomy-facilitated orthodontics in adults using a further modified technique. J Int Acad Periodontol. 2012 Oct;14(4):97-104. PubMed 23210198 ↗
  • Kim SH, Kim I, Jeong DM, Chung KR, Zadeh H. Corticotomy-assisted decompensation for augmentation of the mandibular anterior ridge. Am J Orthod Dentofacial Orthop. 2011 Nov;140(5):720-31. doi: 10.1016/j.ajodo.2009.12.040. PubMed 22051493 ↗
  • 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. PubMed 26108582 ↗
  • Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19. PubMed 11829041 ↗
  • 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. PubMed 20482859 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02574117
Lead sponsor
Cairo University
Responsible party
Noha Ayman Ghallab (Associate Professor of Oral Medicine and Periodontology, Cairo University) — Principal investigator
First posted
Oct 12, 2015
Start date
Apr 2010
Primary completion
May 2014
Completion
Dec 2014
Last update
Apr 7, 2016

Study contacts

Mohammed Khalifa, MD
principal investigator · Associate Professor of Oral and Maxillofacial radiology, Faculty of Oral and Dental Medicine, Cairo University.
Eman Mohii, MD
principal investigator · Lecturer of Orthodontics, Faculty of Oral and Dental Medicine, Cairo University.
Noha Ghallab, MD
principal investigator · Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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