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Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

Primary Purpose

Posterior Cross Bite

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
flap with corticotomy and bone allograft
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Cross Bite

Eligibility Criteria

18 Years - 22 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Oral and Dental Medicine, Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flap with corticotomy and bone allograft

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 8, 2015
Last Updated
April 6, 2016
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02574117
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Cross Bite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flap with corticotomy and bone allograft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
flap with corticotomy and bone allograft
Other Intervention Name(s)
periodontally accelerated orthodontics and DFDBA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inter-arch distance
Description
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 Outcome Measure Information:
Title
Change in tipping angle.
Description
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.
Title
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.
Description
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.
Title
Dehiscence score.
Description
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.
Title
Buccal bone thickness.
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Khalifa, MD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial radiology, Faculty of Oral and Dental Medicine, Cairo University.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eman Mohii, MD
Organizational Affiliation
Lecturer of Orthodontics, Faculty of Oral and Dental Medicine, Cairo University.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noha Ghallab, MD
Organizational Affiliation
Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine, Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
24558526
Citation
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.
Results Reference
background
PubMed Identifier
23210199
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.
Results Reference
background
PubMed Identifier
23210198
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.
Results Reference
background
PubMed Identifier
22051493
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.
Results Reference
background
PubMed Identifier
26108582
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.
Results Reference
background
PubMed Identifier
11829041
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.
Results Reference
background
PubMed Identifier
20482859
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.
Results Reference
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Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

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