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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Efficacy of Injectable Platelet-Rich Plasma (PRP) in Reducing Alveolar Bone Resorption Following Rapid Maxillary Expansion (RME): A Cone Beam Computed Tomogr

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An amount of patient blood will be withdrawn and centrifuged to get PRP.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.


Detailed Summary:

Correction of the maxillary transverse discrepancy is essential for treatment of various types of malocclusions. Palatal expansion is the most common method used to improve the transverse dimensions of the maxilla especially Rapid maxillary expansion (RME) . RME is associated with intermittent high force systems which cause lateral flexion of the alveolar processes and buccal displacement of the anchorage teeth . Displacement of these teeth outside the alveolar anatomic limits can damage the periodontium and finally compromising tooth longevity.

Several researchers have studied the incidence of buccal dehiscence and fenestrations after RME , using CBCT Images.

From here It was thought about using a method to eliminate these dangerous side effects. It was found that platelet rich plasma (PRP) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).

This is the first study in the world that will use PRP with orthodontic treatment, because of its benefits and easiness of using in dental clinic.

Study sample, that consists of 16 patients, was calculated using (G-power sample size calculator) depending on the buccal alveolar bone thickness changes, with a study power of 95%.

Sample will be chosen from the patients who are coming to Orthodontic department in the Faculty of dentistry - Damascus university.

Allocation of the sides of intervention (PRP injection) and control sides is made by letting the participants to withdraw a closed envelop from a dark black box. Each envelop in the box contain either (R letter) for the right side or (L letter
Sponsor: Damascus University

Current Primary Outcome: Changes in buccal alveolar bone height loss and thickness reduction amount [ Time Frame: Evaluation before and after RME. (after 3 months) ]

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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in the appliance supporting teeth inclination [ Time Frame: Evaluation before and after RME. (after 3 months) ]
    The changes in the appliance supporting teeth inclination before and after 3 months of orthodontic expansion. Assessment will be done using CBCT before treatment (T0) and after 3 months (T2)
  • Pain levels [ Time Frame: 3 months ]
    Pain levels accompanying new treatment approach within orthodontic treatment. A questionnaire will be given to the patients on the first day after PRP first injection and after 3 days , 7 days, after 3 months
  • Patient acceptance [ Time Frame: 3 months ]
    Patient acceptance of the PRP injection during comprehensive orthodontic treatments.A questionnaire will be given to the patients on the first day after Prp first injection and after 3 days , 7 days, after 3 months


Original Secondary Outcome: Same as current

Information By: Damascus University

Dates:
Date Received: January 18, 2017
Date Started: July 2016
Date Completion: January 2018
Last Updated: January 18, 2017
Last Verified: January 2017