Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate

Официальное название

Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial

Обзор

The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.

Вмешательства

• Препарат Intervention group (DBM/BMP)
  All patients will undergo a standard procedure for exposure of the cleft alveolar defect and closure of all oronasal fistulae. After induction of general anesthesia, the patient will be intubated with an oral ray tube and prepped and draped in sterile fashion. Pre-operative antibiotics will be given to cover oral flora (i.e. Unasyn or clindamycin if penicillin allergy exists). The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-t
• Препарат Control group(autologous ICBG)
  The patient will be induced with anesthesia, prepped, and draped. The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed.In the control group, the ICBG will be harvested percutaneously using the Accumed bone graft harvesting system. Briefly, an incisio

Первичные конечные точки

• Health system costs per successful bone graft. [Срок оценки: One year post graft]

Вторичные конечные точки (11)

• Graft Success [Срок оценки: 3 months post graft]
• Infection [Срок оценки: 3 months post graft]
• Fistula Recurrence [Срок оценки: 3 months post graft]
• Rate of Revision ABG [Срок оценки: 3 months post graft]
• Operative Time [Срок оценки: 1 day]
• Anesthesia Time [Срок оценки: 1 day]
• Post Operative Pain Scores [Срок оценки: 1 week post operatively]
• Pain Medication Usage [Срок оценки: 1 week post operatively]
• Post Op Fever [Срок оценки: 3 months]
• Drainage from Fistula [Срок оценки: 3 months]
• Post Op ER Visits [Срок оценки: 3 months.]

Критерии участия

Критерии включения

• Patient with CLP(unilateral or bilateral)
• Radiographically evident open bone defect of the alveolus
• Dentition evaluated by orthodontist and cleared for ABG surgery

Критерии исключения

• Patients without CLP
• Previous failed repair of alveolar cleft
• Patients who have previously undergone successful ABG
• Patients without an alveolar defect
• Patients whose parents refuse to consent to randomization
• Patients who have a syndromic CLP

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT04234971 · HSC-MS-19-1027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗