Malocclusion, Angle Class INCT03659097

Acceleration of Alignment of Crowded Lower Anterior Teeth

A study testing periodontally accelerated osteogenic orthodontics in people with Malocclusion, Angle Class I and Crowded Teeth, 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 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… Read more about this study

Who is it for?: Ages 18 to 28 years
Conditions the study is for: Malocclusion, Angle Class I, Crowded Teeth
What is being tested?: periodontally accelerated osteogenic orthodontics
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: 2 Sep 2018to 20 Jun 2021
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

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, University of Damascus Dental School
Damascus, DM20AM18

Other trials in Syria

About this study

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

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.

Conditions: Malocclusion, Angle Class I, Crowded Teeth
Being tested: periodontally accelerated osteogenic orthodontics
Medical subject headings: Malocclusion, Angle Class I, Crowding

What participants receive

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

periodontally accelerated osteogenic orthodonticsProcedure or surgery
Also called PAOO
Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement

Study groups in NCT03659097
Study group	Role	What they receive
Periodontally accelerated osteogenic orthodontics	Experimental	Patients in this group will undergo orthodontic treatment plus periodontally accelerated osteogenic orthodontics in order to induce tooth movement. Receives: Procedure: periodontally accelerated osteogenic orthodontics
Traditional orthodontics	No intervention	Patients in this group will undergo traditional orthodontics without any surgical interventions

What is being measured

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

Duration of Alignment
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Measured: 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
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). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding.
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
Change in Alveolar Defect
Using cone-beam computed tomography (CBCT), each tooth root will be evaluated in axial and cross-sectional slices at the buccal and lingual surfaces. When no cortical bone is observed around the root in at least three sequential views, this will be considered an alveolar defect. If the alveolar bone height is more than 2 mm from the cemento-enamel junction, it will be classified as dehiscence ,When the defect does not involve the alveolar crest, this case will be classified as fenestration.
The status of the alveolar bone will be assessed twice.
Measured: 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 (6)

Change in inter-canine width
The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.
T1: One day before the beginning of treatment; T2: at the end of the alignment stage
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in Alveolar Bone Thickness
Will be measured for each of the lower anterior teeth in the cervical, middle, and apical regions. This will be achieved by using the ruler which will be positioned perpendicular to tooth long axis from the root surface (without measuring the periodontal ligament ) to the most external surface of the cortical bone.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in Lower Incisors' Inclination
The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the positioning of the upper lip
It is going to be evaluated by Ricketts' analysis (E-Line). This is done by drawing a reference line between the tip of the nose and the most prominent point on the chin contour (Pogonion).
The distance of the upper lip from this line is a measure of lip positioning.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the positioning of the lower lip
It is going to be evaluated by Ricketts' analysis (E-Line). This is done by drawing a reference line between the tip of the nose and the most prominent point on the chin contour (Pogonion).
The distance of the lower lip from this line is a measure of lower lip positioning.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the naso-labial angle
It is the angle formed between the lower border of the nose and the upper lip.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

Timeline

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

2 Sep 201820 Jun 2021

First posted6 Sep 2018
Study start2 Sep 2018
Primary completion10 Jan 2021
Study completion20 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: NCT03659097
Sponsor's protocol ID: UDDS-Ortho-17-2018
Status last verified: Aug 2021
First submitted: 3 Sep 2018
Last updated: 19 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27034749
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
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
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
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malocclusion, Angle Class I trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03659097
Acronym / sponsor ID: UDDS-Ortho-17-2018
Conditions: Malocclusion, Angle Class I, Crowded Teeth
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 2 Sep 2018 (actual)
Primary completion: 10 Jan 2021 (actual)
Study completion: 20 Jun 2021 (actual)
First posted: 6 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Periodontally accelerated osteogenic orthodontics	Experimental	Procedure: periodontally accelerated osteogenic orthodonticsPatients in this group will undergo orthodontic treatment plus periodontally accelerated osteogenic orthodontics in order to induce tooth movement.
Traditional orthodontics	No intervention	–Patients in this group will undergo traditional orthodontics without any surgical interventions

Who may qualify

Ages: 18 to 28 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
periodontally accelerated osteogenic orthodonticsAlso: PAOOSurgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement	Procedure or surgery	Periodontally accelerated osteogenic orthodontics

Primary outcome

Duration of Alignment
Time frame: 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
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
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 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). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Change in Alveolar Defect
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Using cone-beam computed tomography (CBCT), each tooth root will be evaluated in axial and cross-sectional slices at the buccal and lingual surfaces. When no cortical bone is observed around the root in at least three sequential views, this will be considered an alveolar defect. If the alveolar bone height is more than 2 mm from the cemento-enamel junction, it will be classified as dehiscence ,When the defect does not involve the alveolar crest, this case will be classified as fenestration. The status of the alveolar bone will be assessed twice.

6 secondary outcomes

Change in inter-canine width
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in Alveolar Bone Thickness
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in Lower Incisors' Inclination
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the positioning of the upper lip
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the positioning of the lower lip
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the naso-labial angle
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Background: PubMed 27034749Munoz 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.
Background: PubMed 27903250Bahammam 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.
Background: PubMed 24036771Yu 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.
Background: PubMed 18533317Nowzari 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.
Background: PubMed 24455038Amit 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hallaj I Alsino, DDS principal investigator

MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

Mohammad Y Hajeer, DDS MSc PhD study director

Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Issam Khoury, DDS MSc PhD study director

Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing periodontally accelerated osteogenic orthodontics in people with Malocclusion, Angle Class I and Crowded Teeth, 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 19 Aug 2021. 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?

Duration of Alignment (time frame: 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). 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 NCT03659097, 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 19 Aug 2021.