Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

Posterior Cross Bite Clinical Trial

Official title:

Corticotomy-assisted Slow Maxillary Expansion With Bone Allograft Assessed With Cone Beam Computed Tomography in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574117
• Other study ID #: Corticotomy_CBCT
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: April 6, 2016
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 22 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posterior Cross Bite

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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.	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.	No
Secondary	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.	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.	No
Secondary	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.	Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years.	No
Secondary	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.	First follow up at 8 months. Second follow up after 2.5 years.	No