The Effect of Platelet-rich Plasma on the Rate and Type of Orthodontic Tooth Movement

NCT ID: NCT06133361

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-24

Study Completion Date

2021-12-15

Brief Summary

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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

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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

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Class II Division 1 Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRP group

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.

Group Type EXPERIMENTAL

PRP injection

Intervention Type BIOLOGICAL

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.

Traditional retraction group

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.

Group Type ACTIVE_COMPARATOR

En-masse retraction of upper anterior teeth

Intervention Type PROCEDURE

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.

Interventions

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PRP injection

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.

Intervention Type BIOLOGICAL

En-masse retraction of upper anterior teeth

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.

Intervention Type PROCEDURE

Other Intervention Names

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platelet-rich plasma (PRP)

Eligibility Criteria

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Inclusion Criteria

1. age range between 16 and 27 years
2. Class II division I malocclusion in which extraction of upper first premolars is indicated
3. skeletal class II relationships (4°\<ANB\<10°),
4. Non-growing patients
5. No maxillary constriction
6. overjet \>5 and \<10 mm
7. normal overbite of 0-50%
8. normal anterior facial height
9. No systemic disease.

Exclusion Criteria

1. patients who have undergone previous orthodontic treatment
2. patients who need orthopedic surgery
3. moderate to severe anterior crowding (Disharmony Dento-Maxillary (DDM≥3)
4. Poor oral hygiene,
5. long-term use of medical drugs, especially NSAIDs
Minimum Eligible Age

16 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Orthodontics, Department of Orthodontics, Faculty of Dentistry, University of Damascus

Locations

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Department of Orthodontics, Faculty of Dentistry, Aleppo University

Aleppo, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 31772456 (View on PubMed)

Ozaki 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.

Reference Type BACKGROUND
PMID: 25610497 (View on PubMed)

Al-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.

Reference Type BACKGROUND
PMID: 25128922 (View on PubMed)

Al-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.

Reference Type BACKGROUND
PMID: 31794163 (View on PubMed)

Gulec 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.

Reference Type BACKGROUND
PMID: 28024792 (View on PubMed)

Angel 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.

Reference Type BACKGROUND
PMID: 34491291 (View on PubMed)

Al-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.

Reference Type BACKGROUND
PMID: 23787192 (View on PubMed)

Other Identifiers

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UDDS-Ortho-13-2023

Identifier Type: -

Identifier Source: org_study_id

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