NCT05390320

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

May 20, 2022

Last Update Submit

May 20, 2022

Conditions

Keywords

PAOOmoderate crowdinggingival indexplaque indexpapillary bleeding index

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

EXPERIMENTAL

The patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.

Procedure: PAOO

Conventional treatment

ACTIVE COMPARATOR

The patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.

Other: Fixed appliance

Interventions

PAOOPROCEDURE

Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.

Periodontally accelerated osteogenic orthodontics

Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.

Conventional treatment

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 24036771BACKGROUND
  • 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.

    PMID: 25347045BACKGROUND
  • 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.

    PMID: 27903250BACKGROUND
  • 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.

    PMID: 24455038BACKGROUND
  • 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.

    PMID: 18533317BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Hallaj I Alsino, DDS

    Department of orthodontics, Damascus University, Syria

    PRINCIPAL INVESTIGATOR
  • 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 DIRECTOR

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

Locations