SERUM BMP-2 AND OSTEOCALCIN LEVELS, AND CT HOUNSFIELD UNIT POST HYPERBARIC OXYGEN THERAPY IN PATIENTS WITH CLEFT LIFT AND PALATE RECEIVING ALVEOLAR BONE GRAFT

Phase 1

Completed

• Conditions: Patients with Cleft lip and palate; alveolar bone graft; hyperbaric oxygen therapy; Cleft lip and palate; Hounsfield unit; osteocalcin; BMP-2

• Registration Number: TCTR20220926001
• Lead Sponsor: Self-funding

Brief Summary

The results showed bone growth in the alveolar defect that had been given a bone graft from the patient's own iliac bone; significant improvements were also observed in the postoperative wound and postoperative laboratory results.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-31
• Study Start: 2022-09-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Patients with CLP and all patients were 12 years old or older

Exclusion Criteria

1) bad oral hygiene (for example, one excluded patient had periodontitis); (2) suboptimal nutritional status, marked by a body index under the 5th percentile in the CDC development curve; and (3) contraindications for HBOT (such as untreated pneumothorax, COPD, barotrauma, asthma, epilepsy, and Eustachian tube dysfunction).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the levels of BMP-2, osteocalcin, and 3D CT scan ng/ml and Hounsfield unit ELISA essay and Hounsfield unit

Secondary Outcome Measures

Name	Time	Method
Characteristics of Patients immediately after alveolar bone graft surgery (fifth day of the surgery, the patients received successive HBOT treatments) Sex, complete blood count, albumin, vitamin D