Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedMay 25, 2022
May 1, 2022
9 months
May 20, 2022
May 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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
Change in the inter-canine width
The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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.
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Secondary Outcomes (3)
Change in the Gingival index
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Change in the Plaque index
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Change in the Papillary Bleeding Index
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Study Arms (2)
Periodontally accelerated osteogenic orthodontics
EXPERIMENTALThe patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.
Conventional treatment
ACTIVE COMPARATORThe patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.
Interventions
Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.
Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.
Eligibility Criteria
You may qualify if:
- 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)
- to 3 mm of overjet and 1 to 4 mm of the overbite
- good oral health
You may not qualify if:
- medical, social, and psycho contraindications to oral surgery
- presence of periodontal diseases
- poor oral hygiene
- previous orthodontic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Damascus
Damascus, Syria
Related Publications (5)
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.
PMID: 24036771BACKGROUNDWu 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.
PMID: 25347045BACKGROUNDBahammam 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.
PMID: 27903250BACKGROUNDAmit 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.
PMID: 24455038BACKGROUNDNowzari 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.
PMID: 18533317BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hallaj I Alsino, DDS
Department of orthodontics, Damascus University, Syria
- STUDY DIRECTOR
Mohammad Y Hajeer, DDS,MSc,PhD
Department of orthodontics, Damascus University, Syria
- STUDY DIRECTOR
Issam Khoury, DDS,MSc,PhD
Department of Oral and Maxillofacial Surgery, Damascus University, Syria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2022
First Posted
May 25, 2022
Study Start
January 1, 2021
Primary Completion
October 6, 2021
Study Completion
February 1, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share