Using Platelet Rich Plasma in Reducing Alveolar Bone Resorption During Rapid Maxillary Expansion
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional
Phase: Phase 1

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      An amount of patient blood will be withdrawn and centrifuged to get PRP.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 description: 
      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) for the left side that will be the
      intervention side for that patient.

      After ensuring of the patients compliance with the terms and conditions of this study, the
      purpose and methods of the study will be explained to the patients using Information Sheet .
      In case of approval to participate the patients asked to sign the Informed Consent.

      Extra & Intra-oral photographs , impressions and clinical examination will be made.

      High resolution CBCT will be taken before the beginning of treatment (T0). Hyrax appliance
      will be applied on the first molars and first premolars and cemented using GIC.

      After one day of cementation, 20ml of patients' blood will be withdrawn and centrifuged to
      get 4 ml of PRP.

      The buccal soft tissue will be anesthetized (sub-mucosal) in the intervention side , then the
      PRP will be injected at the buccal area of the first molar and first premolar in that side
      using insulin syringe , 2 ml for each tooth mentioned in two points. The first point place is
      in the middle of the attached gingiva over the mesial root of the first molar and buccal root
      of the first premolar. The second point is in the mucosal-gingival junction over the same
      root of each tooth.

      Starting of expansion will be done in the same day of injection, twice a day until getting an
      over correction of 2-3 mm.

      After one week, the injection of prp will be repeated in the same way (T1) High resolution
      CBCT for the maxilla will be taken 3 months after the beginning of treatment (T2).

      All measures will be analyzed before and after treatment between two sides. A questionnaire
      will be given to the patients to study pain level accompanying PRP injection compared to the
      control side . Pain will be assessed using Visual Analogue Scale (VAS) 1 (No Pain) - 10
      (Worst Pain).

      A questionnaire will be given to the patients to study their acceptance of new treatment
      approach with comprehensive orthodontic treatments.
    

Intervention name(s): Platelet Rich Plasma; No Platelet Rich Plasma
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): PRP; No PRP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet-rich plasma; Rapid maxillary expansion; Buccal bone thickness; Alveolar bone loss; Alveolar bone resorption