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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05390320
Other study ID # UDDS-Ortho-10-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date February 1, 2022

Study information

Verified date May 2022
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date February 1, 2022
Est. primary completion date October 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
PAOO
Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.
Other:
Fixed appliance
Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.

Locations

Country Name City State
Syrian Arab Republic University of Damascus Damascus

Sponsors (1)

Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change in the Gingival index Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Secondary 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 T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Secondary 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. T0: One day before the beginning of treatment; T1: at the end of the alignment stage
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