Posterior Cross BiteNCT02574117
Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion
A study testing flap with corticotomy and bone allograft in people with Posterior Cross Bite, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posterior Cross Bite
- What is being tested?
- flap with corticotomy and bone allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult female patients (18-22 years) suffering from maxillary constriction with bilateral posterior cross-bite.
- Dental arch discrepancy average 12 mm.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corticotomy-assisted Slow Maxillary Expansion With Bone Allograft Assessed With Cone Beam Computed Tomography in Young Adults
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).
- Conditions
- Posterior Cross Bite
- Being tested
- flap with corticotomy and bone allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap with corticotomy and bone allograftProcedure or surgery
Also called periodontally accelerated orthodontics and DFDBA
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.
| Study group | Role | What they receive |
|---|---|---|
| flap with corticotomy and bone allograft | Experimental | 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. Receives: Procedure: flap with corticotomy and bone allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years.
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.
Measured: First follow up at 8 months. Second follow up after 2.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startApr 2010
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Posterior Cross BiteStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574117
- Sponsor's protocol ID
- Corticotomy_CBCT
- Status last verified
- Apr 2016
- First submitted
- 8 Oct 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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 24558526Shoreibah 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 23210199Shoreibah 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 23210198Kim 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 22051493Hassan 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 26108582Wilcko 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 11829041Hassan 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticotomy-assisted Slow Maxillary Expansion With Bone Allograft Assessed With Cone Beam Computed Tomography in Young Adults
- ClinicalTrials.gov ID
- NCT02574117
- Acronym / sponsor ID
- Corticotomy_CBCT
- Conditions
- Posterior Cross Bite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flap with corticotomy and bone allograft | Experimental | Procedure: flap with corticotomy and bone allograftMaxillary 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. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult female patients (18-22 years) suffering from maxillary constriction with bilateral posterior cross-bite.
- Dental arch discrepancy average 12 mm.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flap with corticotomy and bone allograftAlso: periodontally accelerated orthodontics and DFDBAA 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. | Procedure or surgery | flap with corticotomy and bone allograft |
Primary outcome
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.
4 secondary outcomes
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.
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.
Dehiscence score.
Time frame: Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years.
Buccal bone thickness.
Time frame: First follow up at 8 months. Second follow up after 2.5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Background: PubMed 24558526Cano 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.
- Background: PubMed 23210199Shoreibah 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.
- Background: PubMed 23210198Shoreibah 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.
- Background: PubMed 22051493Kim 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.
- Background: PubMed 26108582Hassan 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.
- Background: PubMed 11829041Wilcko 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.
- Background: PubMed 20482859Hassan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flap with corticotomy and bone allograft in people with Posterior Cross Bite, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574117, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.