Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

• ClinicalTrials.gov Identifier: NCT02574117
• Recruitment Status: Completed
• First Posted: October 12, 2015
• Last Update Posted: April 7, 2016
• Sponsor: Cairo University
• Information provided by (Responsible Party): Noha Ayman Ghallab, Cairo University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Posterior Cross Bite	Procedure: flap with corticotomy and bone allograft	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Corticotomy-assisted Slow Maxillary Expansion With Bone Allograft Assessed With Cone Beam Computed Tomography in Young Adults
• Study Start Date: April 2010
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm

Intervention/treatment

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; 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.; Other Name: periodontally accelerated orthodontics and DFDBA

Outcome Measures

Primary Outcome Measures :

1. Inter-arch distance [ 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. ]

   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.

Secondary Outcome Measures :

1. Change in tipping angle. [ 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. ]

   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.

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. [ 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. ]

   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.

3. Dehiscence score. [ Time Frame: Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years. ]

   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.

4. Buccal bone thickness. [ Time Frame: First follow up at 8 months. Second follow up after 2.5 years. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 22 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Mohammed Khalifa, MD; Associate Professor of Oral and Maxillofacial radiology, Faculty of Oral and Dental Medicine, Cairo University.
• Principal Investigator: Eman Mohii, MD; Lecturer of Orthodontics, Faculty of Oral and Dental Medicine, Cairo University.
• Principal Investigator: Noha Ghallab, MD; Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

More Information

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. Review.

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.

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.

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.

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. Review.

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.

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.

• Responsible Party: Noha Ayman Ghallab, Associate Professor of Oral Medicine and Periodontology, Cairo University
• ClinicalTrials.gov Identifier: NCT02574117
• Other Study ID Numbers: Corticotomy_CBCT
• First Posted: October 12, 2015
• Last Update Posted: April 7, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Malocclusion; Tooth Diseases; Stomatognathic Diseases