Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

Not Applicable

Completed

• Conditions: Posterior Cross Bite
• Interventions: Procedure: flap with corticotomy and bone allograft

• Registration Number: NCT02574117
• Lead Sponsor: Cairo University

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).

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flap with corticotomy and bone allograft	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.

Primary Outcome Measures

Name	Time	Method
Inter-arch distance	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

Name	Time	Method
Dehiscence score.	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.
Change in tipping angle.	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.
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 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.
Buccal bone thickness.	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.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University; 🇪🇬 Cairo, Egypt