Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03764189
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 7, 2018
Information provided by (Responsible Party):
Nashwa abdel mohsen mohamed, Cairo University

Brief Summary:
accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.

Condition or disease Intervention/treatment Phase
Class II Division 1 Malocclusion Procedure: microosteoperforation Not Applicable

Detailed Description:
the study contains 2 groups each contains 13 subjects, A control group (anterior segment retraction with the help of miniscrews) and an intervention group ( anterior segment retraction with the help of miniscrews and microosteoperforation)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: not possible as the subject will sign an informed consent and areas of microosteoperforation will be apparent
Primary Purpose: Treatment
Official Title: Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction: A Randomized Controlled Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
No Intervention: en masse retraction only
anterior segment retraction on miniscrews without microosteoperforation
Active Comparator: en masse retraction with alveocentesis
anterior segment retraction on miniscrews with microosteoperforation
Procedure: microosteoperforation
small holes made using large round bur
Other Names:
  • accelerated tooth movement
  • alveocentesis

Primary Outcome Measures :
  1. Rate of En-masse retraction [ Time Frame: three to six months ]
    retracting six anterior teeth

Secondary Outcome Measures :
  1. Root resorption affecting the six anterior teeth. [ Time Frame: three to six months ]
    Amount of root volume loss analyzed through CBCT software

  2. Tipping affecting the anterior teeth. [ Time Frame: three to six months ]
    Changes in angular measurements calculated through CBCT software

  3. Extrusion of anterior teeth [ Time Frame: three to six months ]
    Linear measurement changes in the clinical height using CBCT

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Females with an age ranging between 16-30 years.
  • Malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
  • Healthy dental and periodontal condition with a good oral hygiene
  • Absence of degenerative conditions.
  • Full set of permanent dentition.

Exclusion Criteria:

  • Medically compromised patients.
  • Previous orthodontic treatment
  • Patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement
  • Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).
  • Active periodontal affection or severe gingival inflammation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03764189

Contact: Nashwa abdel m mohamed, master 01020271313
Contact: Eman m el sayed, Phd 01005289453

Cairo University Recruiting
Cairo, Giza, Egypt, 12566
Contact: Nashwa abdel m mohamed    1020271313      
Sponsors and Collaborators
Cairo University
Study Director: Mohamed A Kaddah, Phd Cairo u

Publications of Results:
Other Publications:
Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4
Blanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21
Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier

Responsible Party: Nashwa abdel mohsen mohamed, principal investigator, Cairo University Identifier: NCT03764189     History of Changes
Other Study ID Numbers: CEBD-CU-2018-11-41
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All patients' personal data of the patient will be kept safely and no patient data will be used outside the trial unless approved by the patient.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nashwa abdel mohsen mohamed, Cairo University:
Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation

Additional relevant MeSH terms:
Malocclusion, Angle Class II
Tooth Diseases
Stomatognathic Diseases