Class II Division 1 MalocclusionNCT06133361
The Effect of Platelet-rich Plasma on the Rate and Type of Orthodontic Tooth Movement
A study testing PRP injection and En-masse retraction of upper anterior teeth in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to assess the effect of PRP on the rate and type of OTM during en-masse frictionless retraction of maxillary anterior teeth using a segmental arch technique. Thirty adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will… Read more about this study
- Who is it for?
- Ages 16 to 27 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- PRP injection and En-masse retraction of upper anterior teeth
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 24 Feb 2019to 15 Dec 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 16 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age range between 16 and 27 years
- Class II division I malocclusion in which extraction of upper first premolars is indicated
- skeletal class II relationships (4°<ANB<10°),
- Non-growing patients
- No maxillary constriction
- overjet >5 and <10 mm
Show all 9Show fewer
- normal overbite of 0-50%
- normal anterior facial height
- No systemic disease.
Who cannot join
- patients who have undergone previous orthodontic treatment
- patients who need orthopedic surgery
- moderate to severe anterior crowding (Disharmony Dento-Maxillary (DDM≥3)
- Poor oral hygiene,
- long-term use of medical drugs, especially NSAIDs
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, Aleppo University
Aleppo, AI20 3JZ
About this study
Official title: Evaluation of the Rate and Type of Orthodontic Tooth Movement When Injecting Platelet-rich Plasma During Mini-implant-based Segmented En-masse Retraction of Upper Anterior Teeth: A Randomized Controlled Clinical Trial
This study aims to assess the effect of PRP on the rate and type of OTM during en-masse frictionless retraction of maxillary anterior teeth using a segmental arch technique.
Thirty adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study. They will be randomly and equally distributed into the PRP group (G1) and the control group (G2). The injection of PRP will be performed pre-retraction. The rate of orthodontic tooth movement will be assessed clinically by measuring the extraction space with a digital caliper. The cephalometric radiographs will evaluate the type of OTM at the beginning of en-masse retraction (T0) and at the middle of en-masse retraction (T1).
Read the detailed description
One of the most important challenges in daily practice is prolonged orthodontic treatment duration. Many therapeutic procedures, such as chemical interventions, have been introduced to minimize orthodontic treatment time. Even though all the methods of chemically assisted acceleration of OTM increase the rate of bone turnover and increase the rate of tooth movement, however, these chemical agents, i.e., hormones or vitamin D3, have many problems such as systemic effects and short half-life which make them not practical in clinical orthodontic. Therefore, the injection of PRP has been proposed.
-In both groups, two first upper premolars were extracted. In all patients, fixed metal orthodontic brackets with MBT prescription 0.022 were bonded. After the arches were leveled and aligned, a rigid sectional archwire (0.021 x 0.025 in stainless steel) was used for the anterior six teeth. To strengthen anchorage, microscrews (diameter 1.6 mm; length 10 mm) were inserted at 8mm from the archwire into the inter-radicular space between the maxillary first molar and second premolar.
Two crimpable hooks were used with a height of 8 mm between the lateral incisor and canine on both sides of the sectional wire 0.021x0.025 to pass the force vector as close as possible to the center of resistance. En-masse retraction began one week after premolar extraction, using calibrated nickel-titanium coil springs with 175 g force per side.
-In PRP, 48 ml of blood was collected from the patient in sterile tubes with ACD-A as an anticoagulant. PRP was prepared as follows: Initially, the blood was centrifuged at 2000 rpm for 6 minutes. After separation of the blood, PRP and some Platelet-Poor Plasma (PPP) were collected and mixed in a dry tube, and then a second centrifugation was done at 2700 rpm for 3 minutes. After the second centrifugation, the lower 1/3rd of the tube is PRP. About 4 ml of PRP was collected from the tube, and then the patient was injected with it. After regional anesthesia for pain control, 0.5 ml of PRP was slowly injected submucosally palatal to each tooth from the right canine to the left canine using a 1cc syringe. Paracetamol was described for the patient to control pain and ensure confirming not to use ibuprofen or another NSAIDS. The injection was applied one time.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- PRP injection, En-masse retraction of upper anterior teeth
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionBiological
Also called platelet-rich plasma (PRP)
The PRP will be prepared according to a well-established technique and then injected into the palatal mucosa of the upper anterior teeth before retraction.
En-masse retraction of upper anterior teethProcedure or surgery
The anterior teeth will be moved backward in an en-masse retraction way using a frictionless method. The anterior teeth will be manipulated as one block. Coil springs will be stretched between the power arms (in the anterior area) to the miniscrews placed in the posterior area bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | PRP will be injected in the palatal mucosa of the upper anterior teeth to accelerate orthodontic tooth movement. Patients in this group will undergo en-masse retraction of their upper front teeth using the same technique as the control group. Receives: Biological: PRP injection |
| Traditional retraction group | Active comparator | In this group, patients will undergo en-masse retraction of their upper front teeth using a frictionless method by using coil springs attached between the anterior portion of the dental arch (which is an anterior segment only) to the miniscrews placed between the upper second premolars and the upper first molars. Receives: Procedure: En-masse retraction of upper anterior teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of retraction
Assessment will be performed clinically by measuring the change in the extraction space. The amount of distance being retracted in millimeters will be divided by the duration of retraction in months to estimate the retraction rate.
Measured: At the middle of the retraction procedure (the middle of closing the extraction space); this assessment time is expected to occur within 2 to 3 months and 3 to 4 months after the onset of retraction in the experimental and control groups, respectively
Change in incisors' positions
The position of the incisal edges of the upper incisors will be measured according to a reference plance.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in position of the root apex of the incisor vertically (UIA-v).
This variable represents the distance between the upper root apex and X reference plane (line drawn from ANS to PNS which is called the palatal plane SPP). Lateral cephalograms will be taken, and this variable will be measured in millimeters.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in position of the incisal edge of the incisor vertically (UIE-v).
This variable represents the distance between the upper incisal edge and X reference plane. Lateral cephalograms will be taken and this variable is going to be measured in millimeters.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in position of the root apex of the incisor horizontally (UIA-h)
This variable represents the distance between the upper root apex and Y reference plane (line perpendicular to SPP at lateral PT). Lateral cephalograms will be taken and this variable is going to be measured in millimeters.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in position of the incisal edge of the incisor horizontally (UIE-h)
This variable represents the distance between the upper incisal edge and Y reference line. Lateral cephalograms will be taken and this variable is going to be measured in millimeters.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Secondary outcomes (4)
Change in the UI/SPP angle
This angle represents the inclination of the upper incisors (UI) relative to the palatal plane (or spinal plane SPP) in the sagittal direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in the SNA angle
This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in the ANB angle
This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in Overbite
This variable represents The vertical overlap of the maxillary incisors over the mandibular incisors, measured relative to the incisal edges. Lateral cephalograms will be taken, and this variable will be measured in millimeters.
Measured: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start24 Feb 2019
- Primary completion12 Sep 2020
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 MalocclusionStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Y Hajeer, DDS MSc PhD, Study director, Professor of Orthodontics, Department of Orthodontics, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133361
- Sponsor's protocol ID
- UDDS-Ortho-13-2023
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. Evaluation of Treatment Outcomes of En masse Retraction with Temporary Skeletal Anchorage Devices in Comparison with Two-step Retraction with Conventional Anchorage in Patients with Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. Contemp Clin Dent. 2018 Oct-Dec;9(4):513-523. doi: 10.4103/ccd.ccd_661_18.
PubMed 31772456Ozaki H, Tominaga JY, Hamanaka R, Sumi M, Chiang PC, Tanaka M, Koga Y, Yoshida N. Biomechanical aspects of segmented arch mechanics combined with power arm for controlled anterior tooth movement: A three-dimensional finite element study. J Dent Biomech. 2015 Jan 8;6:1758736014566337. doi: 10.1177/1758736014566337. eCollection 2015.
PubMed 25610497Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1880-9. doi: 10.1016/j.joms.2014.05.003. Epub 2014 May 14.
PubMed 25128922Al-Imam GMF, Ajaj MA, Hajeer MY, Al-Mdalal Y, Almashaal E. Evaluation of the effectiveness of piezocision-assisted flapless corticotomy in the retraction of four upper incisors: A randomized controlled clinical trial. Dent Med Probl. 2019 Oct-Dec;56(4):385-394. doi: 10.17219/dmp/110432.
PubMed 31794163Gulec A, Bakkalbasi BC, Cumbul A, Uslu U, Alev B, Yarat A. Effects of local platelet-rich plasma injection on the rate of orthodontic tooth movement in a rat model: A histomorphometric study. Am J Orthod Dentofacial Orthop. 2017 Jan;151(1):92-104. doi: 10.1016/j.ajodo.2016.05.016.
PubMed 28024792Angel SL, Samrit VD, Kharbanda OP, Duggal R, Kumar V, Chauhan SS, Coshic P. Effects of submucosally administered platelet-rich plasma on the rate of tooth movement. Angle Orthod. 2022 Jan 1;92(1):73-79. doi: 10.2319/011221-40.1.
PubMed 34491291Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
PubMed 23787192
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rate and Type of Orthodontic Tooth Movement When Injecting Platelet-rich Plasma During Mini-implant-based Segmented En-masse Retraction of Upper Anterior Teeth: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06133361
- Acronym / sponsor ID
- UDDS-Ortho-13-2023
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 24 Feb 2019 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 15 Nov 2023 (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.
This study aims to assess the effect of PRP on the rate and type of OTM during en-masse frictionless retraction of maxillary anterior teeth using a segmental arch technique.
Thirty adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study. They will be randomly and equally distributed into the PRP group (G1) and the control group (G2). The injection of PRP will be performed pre-retraction. The rate of orthodontic tooth movement will be assessed clinically by measuring the extraction space with a digital caliper. The cephalometric radiographs will evaluate the type of OTM at the beginning of en-masse retraction (T0) and at the middle of en-masse retraction (T1).
Detailed description
One of the most important challenges in daily practice is prolonged orthodontic treatment duration. Many therapeutic procedures, such as chemical interventions, have been introduced to minimize orthodontic treatment time. Even though all the methods of chemically assisted acceleration of OTM increase the rate of bone turnover and increase the rate of tooth movement, however, these chemical agents, i.e., hormones or vitamin D3, have many problems such as systemic effects and short half-life which make them not practical in clinical orthodontic. Therefore, the injection of PRP has been proposed.
-In both groups, two first upper premolars were extracted. In all patients, fixed metal orthodontic brackets with MBT prescription 0.022 were bonded. After the arches were leveled and aligned, a rigid sectional archwire (0.021 x 0.025 in stainless steel) was used for the anterior six teeth. To strengthen anchorage, microscrews (diameter 1.6 mm; length 10 mm) were inserted at 8mm from the archwire into the inter-radicular space between the maxillary first molar and second premolar.
Two crimpable hooks were used with a height of 8 mm between the lateral incisor and canine on both sides of the sectional wire 0.021x0.025 to pass the force vector as close as possible to the center of resistance. En-masse retraction began one week after premolar extraction, using calibrated nickel-titanium coil springs with 175 g force per side.
-In PRP, 48 ml of blood was collected from the patient in sterile tubes with ACD-A as an anticoagulant. PRP was prepared as follows: Initially, the blood was centrifuged at 2000 rpm for 6 minutes. After separation of the blood, PRP and some Platelet-Poor Plasma (PPP) were collected and mixed in a dry tube, and then a second centrifugation was done at 2700 rpm for 3 minutes. After the second centrifugation, the lower 1/3rd of the tube is PRP. About 4 ml of PRP was collected from the tube, and then the patient was injected with it. After regional anesthesia for pain control, 0.5 ml of PRP was slowly injected submucosally palatal to each tooth from the right canine to the left canine using a 1cc syringe. Paracetamol was described for the patient to control pain and ensure confirming not to use ibuprofen or another NSAIDS. The injection was applied one time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: PRP injectionPRP will be injected in the palatal mucosa of the upper anterior teeth to accelerate orthodontic tooth movement. Patients in this group will undergo en-masse retraction of their upper front teeth using the same technique as the control group. |
| Traditional retraction group | Active comparator | Procedure: En-masse retraction of upper anterior teethIn this group, patients will undergo en-masse retraction of their upper front teeth using a frictionless method by using coil springs attached between the anterior portion of the dental arch (which is an anterior segment only) to the miniscrews placed between the upper second premolars and the upper first molars. |
Who may qualify
- Ages
- 16 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- age range between 16 and 27 years
- Class II division I malocclusion in which extraction of upper first premolars is indicated
- skeletal class II relationships (4°<ANB<10°),
- Non-growing patients
- No maxillary constriction
Key exclusion criteria (5 listed)
- patients who have undergone previous orthodontic treatment
- patients who need orthopedic surgery
- moderate to severe anterior crowding (Disharmony Dento-Maxillary (DDM≥3)
- Poor oral hygiene,
- long-term use of medical drugs, especially NSAIDs
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 |
|---|---|---|
| PRP injectionAlso: platelet-rich plasma (PRP)The PRP will be prepared according to a well-established technique and then injected into the palatal mucosa of the upper anterior teeth before retraction. | Biological | PRP group |
| En-masse retraction of upper anterior teethThe anterior teeth will be moved backward in an en-masse retraction way using a frictionless method. The anterior teeth will be manipulated as one block. Coil springs will be stretched between the power arms (in the anterior area) to the miniscrews placed in the posterior area bilaterally. | Procedure or surgery | Traditional retraction group |
Primary outcome
Rate of retraction
Time frame: At the middle of the retraction procedure (the middle of closing the extraction space); this assessment time is expected to occur within 2 to 3 months and 3 to 4 months after the onset of retraction in the experimental and control groups, respectively
Assessment will be performed clinically by measuring the change in the extraction space. The amount of distance being retracted in millimeters will be divided by the duration of retraction in months to estimate the retraction rate.
Change in incisors' positions
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
The position of the incisal edges of the upper incisors will be measured according to a reference plance.
Change in position of the root apex of the incisor vertically (UIA-v).
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
This variable represents the distance between the upper root apex and X reference plane (line drawn from ANS to PNS which is called the palatal plane SPP). Lateral cephalograms will be taken, and this variable will be measured in millimeters.
Change in position of the incisal edge of the incisor vertically (UIE-v).
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
This variable represents the distance between the upper incisal edge and X reference plane. Lateral cephalograms will be taken and this variable is going to be measured in millimeters.
Change in position of the root apex of the incisor horizontally (UIA-h)
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
This variable represents the distance between the upper root apex and Y reference plane (line perpendicular to SPP at lateral PT). Lateral cephalograms will be taken and this variable is going to be measured in millimeters.
Change in position of the incisal edge of the incisor horizontally (UIE-h)
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
This variable represents the distance between the upper incisal edge and Y reference line. Lateral cephalograms will be taken and this variable is going to be measured in millimeters.
4 secondary outcomes
Change in the UI/SPP angle
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in the SNA angle
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in the ANB angle
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
Change in Overbite
Time frame: First time point (T0): one day before the beginning of retraction. Second time point (T1): in the middle of extraction space closure (expected to be within 2-3 months in the exp. group and 3-4 months in the control group).
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 15 Nov 2023.
- Background: PubMed 31772456Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. Evaluation of Treatment Outcomes of En masse Retraction with Temporary Skeletal Anchorage Devices in Comparison with Two-step Retraction with Conventional Anchorage in Patients with Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. Contemp Clin Dent. 2018 Oct-Dec;9(4):513-523. doi: 10.4103/ccd.ccd_661_18.
- Background: PubMed 25610497Ozaki H, Tominaga JY, Hamanaka R, Sumi M, Chiang PC, Tanaka M, Koga Y, Yoshida N. Biomechanical aspects of segmented arch mechanics combined with power arm for controlled anterior tooth movement: A three-dimensional finite element study. J Dent Biomech. 2015 Jan 8;6:1758736014566337. doi: 10.1177/1758736014566337. eCollection 2015.
- Background: PubMed 25128922Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1880-9. doi: 10.1016/j.joms.2014.05.003. Epub 2014 May 14.
- Background: PubMed 31794163Al-Imam GMF, Ajaj MA, Hajeer MY, Al-Mdalal Y, Almashaal E. Evaluation of the effectiveness of piezocision-assisted flapless corticotomy in the retraction of four upper incisors: A randomized controlled clinical trial. Dent Med Probl. 2019 Oct-Dec;56(4):385-394. doi: 10.17219/dmp/110432.
- Background: PubMed 28024792Gulec A, Bakkalbasi BC, Cumbul A, Uslu U, Alev B, Yarat A. Effects of local platelet-rich plasma injection on the rate of orthodontic tooth movement in a rat model: A histomorphometric study. Am J Orthod Dentofacial Orthop. 2017 Jan;151(1):92-104. doi: 10.1016/j.ajodo.2016.05.016.
- Background: PubMed 34491291Angel SL, Samrit VD, Kharbanda OP, Duggal R, Kumar V, Chauhan SS, Coshic P. Effects of submucosally administered platelet-rich plasma on the rate of tooth movement. Angle Orthod. 2022 Jan 1;92(1):73-79. doi: 10.2319/011221-40.1.
- Background: PubMed 23787192Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
- 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.
Mohammad Y Hajeer, DDS MSc PhD study director
Professor of Orthodontics, Department of Orthodontics, Faculty of Dentistry, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection and En-masse retraction of upper anterior teeth in people with Class II Division 1 Malocclusion, 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 9 inclusion and 5 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 15 Nov 2023. 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?
Rate of retraction (time frame: At the middle of the retraction procedure (the middle of closing the extraction space); this assessment time is expected to occur within 2 to 3 months and 3 to 4 months after the onset of retraction in the experimental and control groups, respectively). The study lists 6 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 NCT06133361, which also lists 7 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 15 Nov 2023.