Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
Primary Purpose
Crowding, Tooth
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
PAOO
Fixed appliance
Sponsored by
About this trial
This is an interventional treatment trial for Crowding, Tooth focused on measuring PAOO, moderate crowding, gingival index, plaque index, papillary bleeding index
Eligibility Criteria
Inclusion Criteria:
- skeletal class I malocclusion (ANB=2-4)
- normal vertical growth pattern.
- moderate crowding of lower anterior teeth (i.e., 4-6 millimeters of a tooth size-arch length discrepancy)
- 1 to 3 mm of overjet and 1 to 4 mm of the overbite
- good oral health
Exclusion Criteria:
- medical, social, and psycho contraindications to oral surgery
- presence of periodontal diseases
- poor oral hygiene
- previous orthodontic treatment
Sites / Locations
- University of Damascus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Periodontally accelerated osteogenic orthodontics
Conventional treatment
Arm Description
The patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.
The patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.
Outcomes
Primary Outcome Measures
Change in Little's Index of Irregularity
The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975).
The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Change in the inter-canine width
The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.
Change in the inter-2nd premolar width
The distance between the central fossae of the lower second premolars. This variable will be measured on plaster models.
Secondary Outcome Measures
Change in the Gingival index
Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation
Change in the Plaque index
Measured by degrees at each tooth: (0) No plaque; (1) thin plaque layer; (2) moderate plaque layer; (3) severe plaque along the gingival margin
Change in the Papillary Bleeding Index
Measured by the severity of any bleeding: (0) No bleeding; (1) a single discreet bleeding point; (2) several isolated bleeding points; (3) the interdental triangle fills with blood shortly after probing; (4) profuse bleeding occurs after probing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05390320
Brief Title
Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
Official Title
Dental and Periodontal Changes Following the Acceleration of Decrowding of Lower Anterior Teeth Using a PAOO Procedure: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
February 1, 2022 (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 the University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched.
This study aims to compare two groups of patients with moderate crowding of the lower anterior teeth. Experimental group: the patients in this group will be treated with periodontally accelerated osteogenic orthodontics Control group: the patients in this group will be treated using fixed appliances without any acceleration method.
Detailed Description
Correction of irregular teeth can take a long time, and this depends on various factors such as the good compliance of the patient, the amount of dental crowding, and the need for extraction in the course of orthodontic treatment.
Many methods have been used to accelerate tooth movement, and recently the PAOO technique has emerged as an effective therapeutic intervention.
PAOO is a promising procedure but only a few cases were reported in the literature. Controlled clinical and histological studies are needed to understand the biology of tooth movement with this procedure, the effect on teeth and bone, post-retention stability, measuring the volume of mature bone formation, and determining the status of the periodontium and roots after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crowding, Tooth
Keywords
PAOO, moderate crowding, gingival index, plaque index, papillary bleeding index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontally accelerated osteogenic orthodontics
Arm Type
Experimental
Arm Description
The patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
The patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.
Intervention Type
Procedure
Intervention Name(s)
PAOO
Intervention Description
Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.
Intervention Type
Other
Intervention Name(s)
Fixed appliance
Intervention Description
Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.
Primary Outcome Measure Information:
Title
Change in Little's Index of Irregularity
Description
The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975).
The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Time Frame
T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months
Title
Change in the inter-canine width
Description
The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.
Time Frame
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Title
Change in the inter-2nd premolar width
Description
The distance between the central fossae of the lower second premolars. This variable will be measured on plaster models.
Time Frame
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Secondary Outcome Measure Information:
Title
Change in the Gingival index
Description
Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation
Time Frame
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Title
Change in the Plaque index
Description
Measured by degrees at each tooth: (0) No plaque; (1) thin plaque layer; (2) moderate plaque layer; (3) severe plaque along the gingival margin
Time Frame
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Title
Change in the Papillary Bleeding Index
Description
Measured by the severity of any bleeding: (0) No bleeding; (1) a single discreet bleeding point; (2) several isolated bleeding points; (3) the interdental triangle fills with blood shortly after probing; (4) profuse bleeding occurs after probing.
Time Frame
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
skeletal class I malocclusion (ANB=2-4)
normal vertical growth pattern.
moderate crowding of lower anterior teeth (i.e., 4-6 millimeters of a tooth size-arch length discrepancy)
1 to 3 mm of overjet and 1 to 4 mm of the overbite
good oral health
Exclusion Criteria:
medical, social, and psycho contraindications to oral surgery
presence of periodontal diseases
poor oral hygiene
previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hallaj I Alsino, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Issam Khoury, DDS,MSc,PhD
Organizational Affiliation
Department of Oral and Maxillofacial Surgery, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24036771
Citation
Yu H, Jiao F, Wang B, Shen SG. Piezoelectric decortication applied in periodontally accelerated osteogenic orthodontics. J Craniofac Surg. 2013;24(5):1750-2. doi: 10.1097/SCS.0b013e3182902c5a.
Results Reference
background
PubMed Identifier
25347045
Citation
Wu J, Jiang JH, Xu L, Liang C, Bai Y, Zou W. A pilot clinical study of Class III surgical patients facilitated by improved accelerated osteogenic orthodontic treatments. Angle Orthod. 2015 Jul;85(4):616-24. doi: 10.2319/032414-220.1. Epub 2014 Oct 27.
Results Reference
background
PubMed Identifier
27903250
Citation
Bahammam MA. Effectiveness of bovine-derived xenograft versus bioactive glass with periodontally accelerated osteogenic orthodontics in adults: a randomized, controlled clinical trial. BMC Oral Health. 2016 Nov 30;16(1):126. doi: 10.1186/s12903-016-0321-x.
Results Reference
background
PubMed Identifier
24455038
Citation
Amit G, Jps K, Pankaj B, Suchinder S, Parul B. Periodontally accelerated osteogenic orthodontics (PAOO) - a review. J Clin Exp Dent. 2012 Dec 1;4(5):e292-6. doi: 10.4317/jced.50822. eCollection 2012 Dec 1.
Results Reference
background
PubMed Identifier
18533317
Citation
Nowzari H, Yorita FK, Chang HC. Periodontally accelerated osteogenic orthodontics combined with autogenous bone grafting. Compend Contin Educ Dent. 2008 May;29(4):200-6; quiz 207, 218.
Results Reference
background
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Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
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