Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention group (DBM/BMP), Control group(autologous ICBG).
- Who it may be relevant to
- Registry conditions: Cleft Lip and Palate. Basic parameters: 6 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
Overview
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.
Interventions
- Drug 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 - Drug 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
Primary outcome measures
- Health system costs per successful bone graft. [Time frame: One year post graft]
Secondary outcome measures (11)
- Graft Success [Time frame: 3 months post graft]
- Infection [Time frame: 3 months post graft]
- Fistula Recurrence [Time frame: 3 months post graft]
- Rate of Revision ABG [Time frame: 3 months post graft]
- Operative Time [Time frame: 1 day]
- Anesthesia Time [Time frame: 1 day]
- Post Operative Pain Scores [Time frame: 1 week post operatively]
- Pain Medication Usage [Time frame: 1 week post operatively]
- Post Op Fever [Time frame: 3 months]
- Drainage from Fistula [Time frame: 3 months]
- Post Op ER Visits [Time frame: 3 months.]
Eligibility criteria
Inclusion criteria
- Patient with CLP(unilateral or bilateral)
- Radiographically evident open bone defect of the alveolus
- Dentition evaluated by orthodontist and cleared for ABG surgery
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT04234971 · HSC-MS-19-1027