- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05390320
Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
Dental and Periodontal Changes Following the Acceleration of Decrowding of Lower Anterior Teeth Using a PAOO Procedure: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Damascus, Syrian Arab Republic
- University of Damascus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Periodontally accelerated osteogenic orthodontics
The patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.
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Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.
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Active Comparator: Conventional treatment
The patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.
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Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Little's Index of Irregularity
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
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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. |
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
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Change in the inter-canine width
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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The distance between the cusp tips of the lower canines.
This variable will be measured on plaster models.
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T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Change in the inter-2nd premolar width
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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The distance between the central fossae of the lower second premolars.
This variable will be measured on plaster models.
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T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Gingival index
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation
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T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Change in the Plaque index
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Measured by degrees at each tooth: (0) No plaque; (1) thin plaque layer; (2) moderate plaque layer; (3) severe plaque along the gingival margin
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T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Change in the Papillary Bleeding Index
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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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.
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T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hallaj I Alsino, DDS, Department of orthodontics, Damascus University, Syria
- Study Director: Issam Khoury, DDS,MSc,PhD, Department of Oral and Maxillofacial Surgery, Damascus University, Syria
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-Ortho-10-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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