Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction
Primary Purpose
Class II Division 1 Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
microosteoperforation
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation
Eligibility Criteria
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
en masse retraction only
en masse retraction with alveocentesis
Arm Description
anterior segment retraction on miniscrews without microosteoperforation
anterior segment retraction on miniscrews with microosteoperforation
Outcomes
Primary Outcome Measures
Rate of En-masse retraction
retracting six anterior teeth
Secondary Outcome Measures
Root resorption affecting the six anterior teeth.
Amount of root volume loss analyzed through CBCT software
Tipping affecting the anterior teeth.
Changes in angular measurements calculated through CBCT software
Extrusion of anterior teeth
Linear measurement changes in the clinical height using CBCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03764189
Brief Title
Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction
Official Title
Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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
Allocation
Randomized
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
en masse retraction only
Arm Type
No Intervention
Arm Description
anterior segment retraction on miniscrews without microosteoperforation
Arm Title
en masse retraction with alveocentesis
Arm Type
Active Comparator
Arm Description
anterior segment retraction on miniscrews with microosteoperforation
Intervention Type
Procedure
Intervention Name(s)
microosteoperforation
Other Intervention Name(s)
accelerated tooth movement, alveocentesis
Intervention Description
small holes made using large round bur
Primary Outcome Measure Information:
Title
Rate of En-masse retraction
Description
retracting six anterior teeth
Time Frame
three to six months
Secondary Outcome Measure Information:
Title
Root resorption affecting the six anterior teeth.
Description
Amount of root volume loss analyzed through CBCT software
Time Frame
three to six months
Title
Tipping affecting the anterior teeth.
Description
Changes in angular measurements calculated through CBCT software
Time Frame
three to six months
Title
Extrusion of anterior teeth
Description
Linear measurement changes in the clinical height using CBCT
Time Frame
three to six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nashwa abdel m mohamed, master
Phone
01020271313
Email
dr.nashwa_87@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eman m el sayed, Phd
Phone
01005289453
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Kaddah, Phd
Organizational Affiliation
Cairo u
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
12566
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashwa abdel m mohamed
Phone
1020271313
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
22284287
Citation
McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.
Results Reference
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Citation
Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4
Results Reference
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PubMed Identifier
3177281
Citation
Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
15334614
Citation
Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
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PubMed Identifier
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Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.
Results Reference
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Citation
Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier
Results Reference
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PubMed Identifier
24182579
Citation
Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
Results Reference
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PubMed Identifier
27275623
Citation
Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
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PubMed Identifier
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Citation
Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
Results Reference
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Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction
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