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

2018년 7월 27일 업데이트: Damascus University

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

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An amount of patient blood will be withdrawn and centrifuged to get PRP.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

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

16

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

10년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 10-16 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)

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Platelet Rich Plasma
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.

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.

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

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.

다른 이름들:
  • No PRP

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in buccal alveolar bone height loss and thickness reduction amount
기간: 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)
Evaluation before and after RME. (after 3 months)

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in the appliance supporting teeth inclination
기간: 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)
Evaluation before and after RME. (after 3 months)
Pain levels
기간: 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
3 months
Patient acceptance
기간: 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
3 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Kinda Sultan, MSc, PhD, Damascus University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 7월 1일

기본 완료 (실제)

2017년 5월 1일

연구 완료 (실제)

2018년 7월 15일

연구 등록 날짜

최초 제출

2017년 1월 18일

QC 기준을 충족하는 최초 제출

2017년 1월 18일

처음 게시됨 (추정)

2017년 1월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 27일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

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아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

뼈 흡수에 대한 임상 시험

Platelet Rich Plasma에 대한 임상 시험

구독하다