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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220926001

Enrollment

Registered

2022-09-26

Start date

2020-10-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Surgical treatment consisted of single-stage reconstructions with alveolar bone grafts.

Experimental Procedure/Surgery

ALVEOLAR BONE GRAFT

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

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

Exclusion criteria

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Indonesia

Contacts

Public ContactMendy Hatibie Oley

Faculty of Medicine, Sam Ratulangi University

mendy.hatibie@unsrat.ac.id062431863786

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026