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Crowding, ToothNCT05390320

Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique

A study testing PAOO and Fixed appliance in people with Crowding, Tooth, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 28 years
Conditions the study is for
Crowding, Tooth
What is being tested?
PAOO and Fixed appliance
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSyria
Study dates
1 Jan 2021to 1 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 28 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • medical, social, and psycho contraindications to oral surgery
  • presence of periodontal diseases
  • poor oral hygiene
  • previous orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • University of Damascus

    Damascus

Other trials in Syria

About this study

Official title: Dental and Periodontal Changes Following the Acceleration of Decrowding of Lower Anterior Teeth Using a PAOO Procedure: A Randomized Controlled Trial

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.

Read the 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.

Conditions
Crowding, Tooth
Being tested
PAOO, Fixed appliance
Keywords
PAOO, moderate crowding, gingival index, plaque index, papillary bleeding index
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAOOProcedure or surgery

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

  • Fixed applianceOther

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

Study groups in NCT05390320
Study groupRoleWhat they receive
Periodontally accelerated osteogenic orthodonticsExperimentalThe patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.
Receives: Procedure: PAOO
Conventional treatmentActive comparatorThe patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.
Receives: Other: Fixed appliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. Change in the inter-canine width

    The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.

    Measured: T0: One day before the beginning of treatment; T1: at the end of the alignment stage

  3. 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.

    Measured: T0: One day before the beginning of treatment; T1: at the end of the alignment stage

Secondary outcomes (3)

  1. Change in the Gingival index

    Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation

    Measured: T0: One day before the beginning of treatment; T1: at the end of the alignment stage

  2. 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

    Measured: T0: One day before the beginning of treatment; T1: at the end of the alignment stage

  3. 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.

    Measured: T0: One day before the beginning of treatment; T1: at the end of the alignment stage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Jan 2021
  3. Primary completion6 Oct 2021
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390320
Sponsor's protocol ID
UDDS-Ortho-10-2022
Status last verified
May 2022
First submitted
20 May 2022
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24036771

  • 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.

    PubMed 25347045

  • 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.

    PubMed 27903250

  • 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.

    PubMed 24455038

  • 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.

    PubMed 18533317

Questions about this trial

What is this clinical trial studying?

A study testing PAOO and Fixed appliance in people with Crowding, Tooth, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Little's Index of Irregularity (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390320, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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