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Completed

NCT Number: NCT02574117

Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

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).

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Key information

Conditions

Posterior Cross Bite

Age range

18 year–22 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

flap with corticotomy and bone allograft

Procedure

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 names: periodontally accelerated orthodontics and DFDBA

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 12, 2015
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.