Using Platelet Rich Plasma in Reducing Alveolar Bone Resorption During Rapid Maxillary Expansion

NCT03028038 | Completed Phase 1 DMC

• 1 other identifier: UDDS-Ortho-04-2016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is effective in reducing alveolar bone loss that happens after each rapid maxillary expansion (RME) on the buccal aspect of the posterior teeth. 16 patients with a skeletal maxillary constriction aged between 10-16 years old will get into orthodontic treatment to widen the maxilla using Hyrax appliance. An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will be injected in one half of each patient mouth in a split-mouth design, beneath the buccal periosteal of the first molars and first premolars, the halves will be chosen randomly. High resolution CBCT images will be taken before and after orthodontic treatment to analyze buccal bone thickness and height changes.

Conditions

Bone Resorption

Keywords

Platelet-rich plasma; Rapid maxillary expansion; Buccal bone thickness; Alveolar bone loss; Alveolar bone resorption

Outcome Measures

Primary Outcomes (1)

• Changes in buccal alveolar bone height loss and thickness reduction amount

  Buccal alveolar bone height loss and thickness reduction amount (The incidence of Dehiscence) as a result of RME (On the intervention compared to non-intervention side) before and after expansion. Assessment will be done using CBCT before treatment (T0) and after 3 months (T2)

  Evaluation before and after RME. (after 3 months)

Secondary Outcomes (3)

• Changes in the appliance supporting teeth inclination

  Evaluation before and after RME. (after 3 months)

• Pain levels

  3 months

• Patient acceptance

  3 months

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

Platelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it.

Drug: Platelet Rich Plasma

No Platelet Rich Plasma

EXPERIMENTAL

No Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion.

Drug: No Platelet Rich Plasma

Interventions

Platelet Rich Plasma DRUG

Platelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it. High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed.

Also known as: PRP

Platelet Rich Plasma

No Platelet Rich Plasma DRUG

No Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion. High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed.

Also known as: No PRP

No Platelet Rich Plasma

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old patients
• Complete emergence of first molars and first premolars
• Clinical maxillary transverse deficiency
• Good oral hygiene (Gingival index \<1) according to Silness \& loe 1964
• ( Plaque index \<1)

You may not qualify if:

• The presence of a medical situations that affects orthodontic treatment and periodontal health
• The presence of drug therapy affect orthodontic treatment and periodontal health
• Bad oral hygiene (gingival and plaque index \>1)
• Patient with physical and psychological limitations
• Metallic restorations or endodontic treatments on the appliance supporting teeth (first molars and first premolars)
• Craniofacial anomalies
• Previous orthodontic treatment
• Patients who did not correctly follow the protocol of activation
• Patients who did not return for control dental appointments
• Patients whose cementation of the appliance failed
• Patients whose dental structures were difficult to visualize on the CBCT scans as a result of artifact

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (11)

• Agarwal A, Gupta ND. Platelet-rich plasma combined with decalcified freeze-dried bone allograft for the treatment of noncontained human intrabony periodontal defects: a randomized controlled split-mouth study. Int J Periodontics Restorative Dent. 2014 Sep-Oct;34(5):705-11. doi: 10.11607/prd.1766.

  PMID: 25171042 RESULT

• Akin M, Baka ZM, Ileri Z, Basciftci FA. Alveolar bone changes after asymmetric rapid maxillary expansion. Angle Orthod. 2015 Sep;85(5):799-805. doi: 10.2319/090214.1. Epub 2014 Dec 5.

  PMID: 25478739 RESULT

• Albanese A, Licata ME, Polizzi B, Campisi G. Platelet-rich plasma (PRP) in dental and oral surgery: from the wound healing to bone regeneration. Immun Ageing. 2013 Jun 13;10(1):23. doi: 10.1186/1742-4933-10-23.

  PMID: 23763951 RESULT

• Baysal A, Uysal T, Veli I, Ozer T, Karadede I, Hekimoglu S. Evaluation of alveolar bone loss following rapid maxillary expansion using cone-beam computed tomography. Korean J Orthod. 2013 Apr;43(2):83-95. doi: 10.4041/kjod.2013.43.2.83. Epub 2013 Apr 25.

  PMID: 23671833 RESULT

• Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.

  PMID: 25722595 RESULT

• DurmuSlar MC, Alpaslan C, Alpaslan G, Cakir M. Clinical and radiographic evaluation of the efficacy of platelet-rich plasma combined with hydroxyapatite bone graft substitutes in the treatment of intra-bony defects in maxillofacial region. Acta Odontol Scand. 2014 Nov;72(8):948-53. doi: 10.3109/00016357.2014.926023. Epub 2014 Jul 9.

  PMID: 25005628 RESULT

• Geramy A, Shahroudi AS. Fixed versus Removable Appliance for Palatal Expansion; A 3D Analysis Using the Finite Element Method. J Dent (Tehran). 2014 Jan;11(1):75-84. Epub 2014 Jan 31.

  PMID: 24910679 RESULT

• Gunyuz Toklu M, Germec-Cakan D, Tozlu M. Periodontal, dentoalveolar, and skeletal effects of tooth-borne and tooth-bone-borne expansion appliances. Am J Orthod Dentofacial Orthop. 2015 Jul;148(1):97-109. doi: 10.1016/j.ajodo.2015.02.022.

  PMID: 26124033 RESULT

• Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.

  PMID: 25490552 RESULT

• Martinez CE, Gonzalez SA, Palma V, Smith PC. Platelet-Poor and Platelet-Rich Plasma Stimulate Bone Lineage Differentiation in Periodontal Ligament Stem Cells. J Periodontol. 2016 Feb;87(2):e18-26. doi: 10.1902/jop.2015.150360. Epub 2015 Sep 14.

  PMID: 26367495 RESULT

• Alomari EB, Sultan K. Efficacy of injectable platelet-rich plasma in reducing alveolar bone resorption following rapid maxillary expansion: A cone-beam computed tomography assessment in a randomized split-mouth controlled trial. Angle Orthod. 2019 Sep;89(5):705-712. doi: 10.2319/091018-661.1. Epub 2019 Mar 28.

  PMID: 30920874 DERIVED

MeSH Terms

Conditions

Bone Resorption; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kinda Sultan, MSc, PhD

  Damascus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 15, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)