Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth
Primary Purpose
Crowding of Anterior Mandibular Teeth
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Corticision
Traditional Non-accelerated Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Crowding of Anterior Mandibular Teeth
Eligibility Criteria
Inclusion Criteria:
- Age range between 18 and 24 years
- Completion permanent dentition (except third molars)
- Mild to moderate crowding (2-6 mm according to Little's index)
- Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Exclusion Criteria:
- Medical conditions that would affect tooth movement.
- Cases which contraindication to oral surgery.
- Previous orthodontic treatments.
Sites / Locations
- Orthodontic Department, University of Damascus Dental School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Corticision
Traditional treatment
Arm Description
Patients in this group will be subjected to corticision to accelerate orthodontic movement
Patients in this group will undergo normal traditional treatment without any acceleration method.
Outcomes
Primary Outcome Measures
Change in Root Length
Cone-beam computed tomography imaging will be used for the lower jaw. Root length will be measured for each root of the six lower anterior teeth The change will be calculated between 'before' and 'after' images in mm.
Secondary Outcome Measures
Change in Dehiscence Proportion
Cone-beam computed tomography imaging will be used for the lower jaw. Any V-shaped bone defect located buccally or lingually in the lower anterior region involving bone margin is preliminarily identified as dehiscence. This is going to be measured and the proportion of the presence of such defects will be calculated on two different occasions (T1 and T2).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04601662
Brief Title
Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth
Official Title
Evaluation of Corticision-Based Acceleration of Lower Anterior Teeth Alignment on Root Resorption and Dehiscence Formation Using CBCT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus 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
The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.
Researchers used minimally invasive surgical methods like corticision, piezocision, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40%.
The effect of corticision as a minimally invasive procedure on root resorption and dehiscence formation during orthodontic tooth movement has not been studied yet.
Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.
Detailed Description
Orthodontically induced external root resorption accompanying orthodontic treatment is defined as a microscopic loss of root tissue as a result of the inflammatory reaction that occurs in the area of application of orthodontic force. It can be diagnosed and measured using conventional radiography or cone-beam computed tomography (CBCT).
Dehiscence is a loss of alveolar bone on the facial (rarely lingual) aspect of a tooth that leaves a characteristic v-shaped, root-exposed defect from the cementoenamel junction apically. Bone dehiscence cannot be detected through conventional radiography or clinical examination. Actually, CBCT can be considered the best accessible technique providing 3D data.
Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.
No randomized controlled trial (RCT) has compared flapless corticision in the non-extraction-based orthodontic decrowding of lower anterior teeth (LAT) with the conventional treatment in terms of external apical root resorption (EARR) and dehiscence formation (DF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crowding of Anterior Mandibular Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corticision
Arm Type
Experimental
Arm Description
Patients in this group will be subjected to corticision to accelerate orthodontic movement
Arm Title
Traditional treatment
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo normal traditional treatment without any acceleration method.
Intervention Type
Procedure
Intervention Name(s)
Corticision
Intervention Description
A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth
Intervention Type
Other
Intervention Name(s)
Traditional Non-accelerated Treatment
Intervention Description
The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods
Primary Outcome Measure Information:
Title
Change in Root Length
Description
Cone-beam computed tomography imaging will be used for the lower jaw. Root length will be measured for each root of the six lower anterior teeth The change will be calculated between 'before' and 'after' images in mm.
Time Frame
T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
Secondary Outcome Measure Information:
Title
Change in Dehiscence Proportion
Description
Cone-beam computed tomography imaging will be used for the lower jaw. Any V-shaped bone defect located buccally or lingually in the lower anterior region involving bone margin is preliminarily identified as dehiscence. This is going to be measured and the proportion of the presence of such defects will be calculated on two different occasions (T1 and T2).
Time Frame
T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range between 18 and 24 years
Completion permanent dentition (except third molars)
Mild to moderate crowding (2-6 mm according to Little's index)
Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Exclusion Criteria:
Medical conditions that would affect tooth movement.
Cases which contraindication to oral surgery.
Previous orthodontic treatments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Radwan Sirri, DDS MSc
Organizational Affiliation
PhD student, Orthodontics Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmad S Burhan, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, University of Damascus, Damascus, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fehmieh R Nawaya, DDS MSc PhD
Organizational Affiliation
Associate Professor of Pedodontics, Syrian Private University, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Orthodontic Department, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28967331
Citation
Mandelaris GA, Neiva R, Chambrone L. Cone-Beam Computed Tomography and Interdisciplinary Dentofacial Therapy: An American Academy of Periodontology Best Evidence Review Focusing on Risk Assessment of the Dentoalveolar Bone Changes Influenced by Tooth Movement. J Periodontol. 2017 Oct;88(10):960-977. doi: 10.1902/jop.2017.160781.
Results Reference
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PubMed Identifier
27129491
Citation
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
Results Reference
background
PubMed Identifier
30994445
Citation
Charavet C, Lambert F, Lecloux G, Le Gall M. [Accelerated orthodontic treatment using corticotomies: what are the minimally invasive alternatives?]. Orthod Fr. 2019 Mar;90(1):5-12. doi: 10.1051/orthodfr/2019002. Epub 2019 Apr 17. French.
Results Reference
background
PubMed Identifier
23092202
Citation
Makedonas D, Lund H, Hansen K. Root resorption diagnosed with cone beam computed tomography after 6 months and at the end of orthodontic treatment with fixed appliances. Angle Orthod. 2013 May;83(3):389-93. doi: 10.2319/042012-332.1. Epub 2012 Oct 23.
Results Reference
background
PubMed Identifier
29771300
Citation
Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027.
Results Reference
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Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth
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