Clinical trial NCT03659097: Acceleration of Alignment of Crowded Lower Anterior Teeth
Official title: Evaluation of the Efficacy of Periodontally Accelerated Osteogenic Orthodontics in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Two-Arm Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class I
Crowded Teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 included. Then, initial diagnostic records (diagnostic gypsum models, 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 two groups of patients with moderate crowding of the lower anterior teeth First group (Experimental): the patients in this group will be treated with orthodontic fixed appliances + surgery to the alveolus of the lower anterior teeth in order to induce remodeling of the bony structures and enhance orthodontic movement.

Second group (Control): the patients in this group will be treated using fixed appliances with any acceleration method.


Eligibility criteria: Inclusion Criteria:

* Class I malocclusion with moderate crowding (4-6 mm of tooth-size-arch-length-discrepancy).
* Good oral hygiene and periodontal health.
* No severe skeletal discrepancy.
* Normal inclination for the upper and lower incisors.
* No congenitally missing or extracted teeth (except for the third molars).

Exclusion Criteria:

* Bi-maxillary severe dental protrusion.
* Previous orthodontic treatment.
* Subject with psychological abnormalities.
* Subject with systemic diseases.

Primary outcomes:
measure: Duration of Alignment
timeFrame: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 5 to 6 months
measure: Change in Little's Index of Irregularity
timeFrame: 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
measure: Change in Alveolar Defect
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Secondary outcomes:
measure: Change in inter-canine width
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
measure: Change in Alveolar Bone Thickness
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
measure: Change in Lower Incisors' Inclination
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
measure: Change in the positioning of the upper lip
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
measure: Change in the positioning of the lower lip
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
measure: Change in the naso-labial angle
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
name: Hallaj I Alsino, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
name: Issam Khoury, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: Munoz F, Jimenez C, Espinoza D, Vervelle A, Beugnet J, Haidar Z. Use of leukocyte and platelet-rich fibrin (L-PRF) in periodontally accelerated osteogenic orthodontics (PAOO): Clinical effects on edema and pain. J Clin Exp Dent. 2016 Apr 1;8(2):e119-24. doi: 10.4317/jced.52760. eCollection 2016 Apr.
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.
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.
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.
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.