Clinical trial NCT05390320: 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
Overall status: COMPLETED
Phase: NA
Conditions: Crowding, Tooth
Keywords: PAOO
moderate crowding
gingival index
plaque index
papillary bleeding index
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-05-25
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 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.

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

Primary outcomes:
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 the inter-canine width
timeFrame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
measure: Change in the inter-2nd premolar width
timeFrame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Secondary outcomes:
measure: Change in the Gingival index
timeFrame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
measure: Change in the Plaque index
timeFrame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
measure: Change in the Papillary Bleeding Index
timeFrame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Hallaj I Alsino, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of Oral and Maxillofacial Surgery, Damascus University, Syria
name: Issam Khoury, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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: 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.
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: 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.
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.