The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time

NCT05335824 | Completed DMC

• 1 other identifier: UHDS-Ortho-07-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups: (1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.

Conditions

Class II Division 1 Malocclusion

Keywords

Platelet-rich plasma; Platelet-rich fibrin; Acceleration

Outcome Measures

Primary Outcomes (1)

• Change in canine retraction rate

  The amount of canine retraction per month was calculated by measuring the distance from the canine cusp tip in the baseline model to the canine cusp tip in the next superimposed model. The amount of distance being retracted in millimeters was divided to the duration of retraction in months to give an estimation of the retraction rate.

  The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0

Secondary Outcomes (2)

• Change in the maxillary first molar position (anchorage loss)

  T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction

• Change in canine rotation

  T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction

Study Arms (3)

The platelet-rich plasma (PRP) group:

EXPERIMENTAL

The patients in this group received PRP injections immediately before the canine retraction, and after 8 weeks of the onset of retraction

Other: The platelet-rich plasma (PRP)

The injectable platelet-rich fibrin (I-PRF) group

EXPERIMENTAL

The patients in this group received I-PRF injections immediately before the canine retraction, and after 8 weeks of the onset of retraction

Other: The injectable platelet-rich fibrin (I-PRF) group

The control group

ACTIVE COMPARATOR

The patients in this group did not receive any injections

Device: The control group

Interventions

The platelet-rich plasma (PRP) OTHER

Twenty ml of venous blood was drawn from each patient with the use of PRP tubes that contain anticoagulant citrate dextrose. The double-spin technique was used to prepare the PRP. The injection areas were anesthetized with lidocaine 2% with epinephrine 1/80000 and left for 10 minutes. 15 units (0. 15 mL) of PRP were injected interaligamentlly in the middle, distobuccal, and distopalatal areas of the distal surface of the upper canines (5 units in each area) together with submucosal injections buccally and palatally (100 units and 50 units , respectively).

The platelet-rich plasma (PRP) group:

The injectable platelet-rich fibrin (I-PRF) group OTHER

Twenty ml of venous blood was drawn from each patient in this experimental group. I-PRF was prepared with the use of 20 ml of blood drawn from the patient in dry sterile tubes without anticoagulant (quickly before coagulation starts) by following the centrifugation protocol requires one cycle only (700 RPM for 3 minutes) Injection procedures, sites, and time were similar to the PRP group.

The injectable platelet-rich fibrin (I-PRF) group

The control group DEVICE

NiTi closed-coil springs (American Orthodontics, Sheboygan, WI) were used to impose 150 g force from the first molar band hook to the bracket of canine on each side on 0.019\*0.025-in SS archwire Patients' follow-up appointments were two weeks intervals; at each visit, the force produced by the coil was checked and readjusted when needed in order to keep it at 150-g level and the appliances were examined for any deformation or change in the position because of chewing. Canine retraction continued until achieving Class I canine relationship.

The control group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• both male and female subjects
• years old
• Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars
• Full permanent dentition
• Good general and oral health

You may not qualify if:

• extreme skeletal class II malocclusion, overjet \> 10 mm ANB\>7◦
• diseases and medications that were likely to affect bone biology
• poor oral hygiene
• previous orthodontic treatment
• smoking
• coagulation disorders, or being treated with anticoagulants

Sponsors & Collaborators

• Damascus University: lead
• Hama University: collaborator

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (7)

• Rashid A, ElSharaby FA, Nassef EM, Mehanni S, Mostafa YA. Effect of platelet-rich plasma on orthodontic tooth movement in dogs. Orthod Craniofac Res. 2017 May;20(2):102-110. doi: 10.1111/ocr.12146.

  PMID: 28414871 BACKGROUND

• Tehranchi A, Behnia H, Pourdanesh F, Behnia P, Pinto N, Younessian F. The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial. Eur J Dent. 2018 Jul-Sep;12(3):350-357. doi: 10.4103/ejd.ejd_424_17.

  PMID: 30147398 BACKGROUND

• Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.

  PMID: 32591274 BACKGROUND

• Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.

  PMID: 33481053 BACKGROUND

• Ali Mahmood TM, Chawshli OF. The Effect of Submucosal Injection of Plasma-Rich Platelets on Blood Inflammatory Markers for Patients with Bimaxillary Protrusion Undergoing Orthodontic Treatment. Int J Inflam. 2019 Oct 1;2019:6715871. doi: 10.1155/2019/6715871. eCollection 2019.

  PMID: 31662844 BACKGROUND

• Dixon V, Read MJ, O'Brien KD, Worthington HV, Mandall NA. A randomized clinical trial to compare three methods of orthodontic space closure. J Orthod. 2002 Mar;29(1):31-6. doi: 10.1093/ortho/29.1.31.

  PMID: 11907307 BACKGROUND

• Ammar AM, Al-Sabbagh R, Hajeer MY. Evaluation of the effectiveness of the platelet-rich plasma compared to the injectable platelet-rich fibrin on the rate of maxillary canine retraction: a three-arm randomized controlled trial. Eur J Orthod. 2024 Jan 1;46(1):cjad056. doi: 10.1093/ejo/cjad056.

  PMID: 37796117 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

proliferation regulatory factors, human urine; Population Groups

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Ali Ammar, DDS, MSc

  Department of orthodontics, Hama University, Syria

  PRINCIPAL INVESTIGATOR

• Rabab al-Sabbagh, DDS,MSc,PhD

  Department of orthodontics, Hama University, Syria

  STUDY DIRECTOR

• Mohammad Y Hajeer, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  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: April 8, 2022
• First Posted: April 19, 2022
• Study Start: February 8, 2019
• Primary Completion: May 12, 2019
• Study Completion: December 25, 2020
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)