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

NCT06133361 | Completed DMC

• 1 other identifier: UDDS-Ortho-13-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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).

Study Arms (2)

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.

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.

Procedure: En-masse retraction of upper anterior teeth

Interventions

PRP injection 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.

Also known as: platelet-rich plasma (PRP)

PRP group

En-masse retraction of upper anterior teeth 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.

Traditional retraction group

Eligibility Criteria

• Age: 16 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• normal overbite of 0-50%
• normal anterior facial height
• No systemic disease.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, Aleppo University

Aleppo, AI20 3JZ, Syria

Location

Related Publications (7)

• 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.

  PMID: 31772456 BACKGROUND

• 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.

  PMID: 25610497 BACKGROUND

• 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.

  PMID: 25128922 BACKGROUND

• 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.

  PMID: 31794163 BACKGROUND

• 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.

  PMID: 28024792 BACKGROUND

• 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.

  PMID: 34491291 BACKGROUND

• 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.

  PMID: 23787192 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammad Y Hajeer, DDS MSc PhD

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

  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: November 10, 2023
• First Posted: November 15, 2023
• Study Start: February 24, 2019
• Primary Completion: September 12, 2020
• Study Completion: December 15, 2021
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)