Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion
Primary Purpose
Malocclusion of Anterior Teeth
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Self-Ligating Brackets
Traditionally-Ligated Brackets
Corticotomy
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion of Anterior Teeth
Eligibility Criteria
Inclusion Criteria:
- Age of patients: 17-28 years.
- Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
- The Little's Index of Irregularity is over 7 mm.
- There is no previous orthodontic treatment.
- The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
- The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
- Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
- Overbite is between 0-4 mm.
- There is no skeletal constriction on the upper jaw.
- Full presence of all permanent teeth in the dental arch (except for third molars)
Exclusion Criteria:
- Any systemic diseases that would affect tooth movement .
- Any congenital syndromes or cleft lip and palate cases
- Bad oral health
Sites / Locations
- Department of Orthodontics, University of Damascus Dental School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Self-Ligating Brackets
Self-Ligating Brackets with Corticotomy
Traditionally-Ligated Brackets
Arm Description
Patients will be treated using self-ligating brackets to achieve proper alignment of teeth
Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.
Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth
Outcomes
Primary Outcome Measures
Duration of Alignment
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Change in Little's Index
The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is.
Change in inter-canine width lingually
The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models.
Change in inter-canine width
The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.
Change in Canine Rotation Angle
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine.
Change in Lateral Incisor Rotation Angle
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor.
Change in Central Incisor Rotation Angle
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03647241
Brief Title
Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion
Official Title
An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
June 19, 2020 (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
Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.
The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth:
Group 1 : Patients will be treated using self-ligating brackets
Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy.
Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth)
At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.
Detailed Description
The sample of this study will be chosen according the following steps:
The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
A random sample of 100 patients from the sampling frame will be chosen.
An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion of Anterior Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Ligating Brackets
Arm Type
Experimental
Arm Description
Patients will be treated using self-ligating brackets to achieve proper alignment of teeth
Arm Title
Self-Ligating Brackets with Corticotomy
Arm Type
Experimental
Arm Description
Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.
Arm Title
Traditionally-Ligated Brackets
Arm Type
Active Comparator
Arm Description
Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth
Intervention Type
Device
Intervention Name(s)
Self-Ligating Brackets
Other Intervention Name(s)
SLBs
Intervention Description
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Intervention Type
Device
Intervention Name(s)
Traditionally-Ligated Brackets
Other Intervention Name(s)
Non-SLBs
Intervention Description
These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.
Intervention Type
Procedure
Intervention Name(s)
Corticotomy
Other Intervention Name(s)
Piezosurgery, Decortication
Intervention Description
Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.
Primary Outcome Measure Information:
Title
Duration of Alignment
Description
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Time Frame
This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)
Title
Change in Little's Index
Description
The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is.
Time Frame
T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months)
Title
Change in inter-canine width lingually
Description
The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models.
Time Frame
T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Title
Change in inter-canine width
Description
The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.
Time Frame
T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Title
Change in Canine Rotation Angle
Description
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine.
Time Frame
T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Title
Change in Lateral Incisor Rotation Angle
Description
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor.
Time Frame
T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Title
Change in Central Incisor Rotation Angle
Description
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor.
Time Frame
T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of patients: 17-28 years.
Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
The Little's Index of Irregularity is over 7 mm.
There is no previous orthodontic treatment.
The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
Overbite is between 0-4 mm.
There is no skeletal constriction on the upper jaw.
Full presence of all permanent teeth in the dental arch (except for third molars)
Exclusion Criteria:
Any systemic diseases that would affect tooth movement .
Any congenital syndromes or cleft lip and palate cases
Bad oral health
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Al-Ibrahim, DDS
Organizational Affiliation
MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Issam Khoury, DDS MSc PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29101414
Citation
Yang X, Xue C, He Y, Zhao M, Luo M, Wang P, Bai D. Transversal changes, space closure, and efficiency of conventional and self-ligating appliances : A quantitative systematic review. J Orofac Orthop. 2018 Jan;79(1):1-10. doi: 10.1007/s00056-017-0110-4. Epub 2017 Nov 3.
Results Reference
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Results Reference
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Yang X, He Y, Chen T, Zhao M, Yan Y, Wang H, Bai D. Differences between active and passive self-ligating brackets for orthodontic treatment : Systematic review and meta-analysis based on randomized clinical trials. J Orofac Orthop. 2017 Mar;78(2):121-128. doi: 10.1007/s00056-016-0059-8. Epub 2017 Feb 21.
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Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion
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