Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement
Primary Purpose
Malocclusion, Angle Class I, Malocclusion; Angle Class II Division 1
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Peizocorticision
Conventional Orthodontic Mechanics
Sponsored by
About this trial
This is an interventional basic science trial for Malocclusion, Angle Class I focused on measuring Accelerated orthodontic tooth movement (AOTM), Peizo-corticission
Eligibility Criteria
Study Subjects for Part I and Part II:
Inclusion:
- Voluntary participation of patients only
- Able to follow instruction, able to understand the consent form and sign it.
- Adult Female and Male Saudi patients 15-35 y.o
- Subjects who are none smokers
- Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
- Subjects with good periodontal and gingival health: Gingival Index GI≤ 1
- Subjects with a none gummy smile,
- Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings
- Subjects without root anomalies
- Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion
Exclusion:
- Subjects younger than 15 y.o
- Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
- Subjects who are medically classified as ASA-II, III
- Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
- Subjects who are pregnant
- Subjects who are smokers
- Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma
- Subjects with unhealthy or compromised periodontium
- Subjects with a gummy smile
- Subjects with inadequately treated endodontic and dental fillings problems
- Subjects with previous root resorption or dental developmental anomalies
- Subjects who had previous orthodontic treatment
- Subjects with TMJ signs and symptoms; Mandibular functional shift
- Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm
- Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.
- Subjects will be excluded if any of mini-screws failed during treatment
- Subjects who become medically unfit during course of trial
Sites / Locations
- National Guard HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional OrthodonticTreatment
Accelerated Tooth Movement
Arm Description
Conventional orthodontic mechanics: canine and incisor retraction
Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction
Outcomes
Primary Outcome Measures
Rate of orthodontic canine movement
Secondary Outcome Measures
Rate of orthodontic Incisor Retraction
Full Information
NCT ID
NCT02549950
First Posted
September 11, 2015
Last Updated
September 14, 2015
Sponsor
AL Yousef
Collaborators
King Abdullah International Medical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02549950
Brief Title
Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement
Official Title
Efficiency and Efficacy of Peizo-Coticision in Reducing Orthodontic Treatment Time: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
AL Yousef
Collaborators
King Abdullah International Medical Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time.
Detailed Description
1 Aim of the study- Part I:
This prospective controlled clinical trial (CCT), Split Mouth Design is conducted to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of canine teeth in class II div 1 subjects.
Specific aim- Part I:
A- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved canines
B- To compare length of treatment of both approaches.
2- Objectives of the Study Part II:
This prospective randomized controlled clinical trial (RCT) is designed to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of anterior teeth in class II div 1 and class 1 bi-maxillary protrusive subjects.
Specific aim Part II:
To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved incisors
To compare length of treatment of both approaches.
To evaluate the quality of treatment outcome of both treatment approaches according to American Board of Orthodontics (ABO) standards.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class I, Malocclusion; Angle Class II Division 1
Keywords
Accelerated orthodontic tooth movement (AOTM), Peizo-corticission
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional OrthodonticTreatment
Arm Type
Active Comparator
Arm Description
Conventional orthodontic mechanics: canine and incisor retraction
Arm Title
Accelerated Tooth Movement
Arm Type
Experimental
Arm Description
Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction
Intervention Type
Procedure
Intervention Name(s)
Peizocorticision
Other Intervention Name(s)
AOTM Accelerated Orthodontic Tooth Movement
Intervention Description
Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement
Intervention Type
Procedure
Intervention Name(s)
Conventional Orthodontic Mechanics
Other Intervention Name(s)
Conv Orth Mech
Intervention Description
Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics
Primary Outcome Measure Information:
Title
Rate of orthodontic canine movement
Time Frame
4-6 months
Secondary Outcome Measure Information:
Title
Rate of orthodontic Incisor Retraction
Time Frame
4-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Study Subjects for Part I and Part II:
Inclusion:
Voluntary participation of patients only
Able to follow instruction, able to understand the consent form and sign it.
Adult Female and Male Saudi patients 15-35 y.o
Subjects who are none smokers
Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
Subjects with good periodontal and gingival health: Gingival Index GI≤ 1
Subjects with a none gummy smile,
Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings
Subjects without root anomalies
Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion
Exclusion:
Subjects younger than 15 y.o
Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
Subjects who are medically classified as ASA-II, III
Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
Subjects who are pregnant
Subjects who are smokers
Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma
Subjects with unhealthy or compromised periodontium
Subjects with a gummy smile
Subjects with inadequately treated endodontic and dental fillings problems
Subjects with previous root resorption or dental developmental anomalies
Subjects who had previous orthodontic treatment
Subjects with TMJ signs and symptoms; Mandibular functional shift
Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm
Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.
Subjects will be excluded if any of mini-screws failed during treatment
Subjects who become medically unfit during course of trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally K Al-Yousef, Msc-Ortho
Phone
00966-11-8011111
Ext
14036
Email
alyousefsa@ngha.med.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally K Al-Yousef, MSc-Ortho
Organizational Affiliation
KAIMRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Guard Hospital
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SALLY K AL-YOUSEF
Phone
00966118011111
Ext
14036
Email
alyousefsa@ngha.med.sa
12. IPD Sharing Statement
Citations:
PubMed Identifier
23810039
Citation
Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.
Results Reference
background
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Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement
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