The effectiveness of rhBMP-2 injected on palatal expansion.

A clinical trial to compare the effect of rhBMP-2 injection and non-injection on palatal expansion in cleft lip and palate patients

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017051533974N1

Enrollment

Registered

2017-06-25

Start date

2017-07-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Cleft lip and palate patients. Cleft palate with cleft lip

Interventions

Intervention 1: Control group: Who is revising standard alveolar bone grafting, the effectiveness of skeletal and dental are examining 4 months after intervention before, as well as immediately and 3

Treatment - Surgery

Control group: Who is revising standard alveolar bone grafting, the effectiveness of skeletal and dental are examining 4 months after intervention before, as well as immediately and 3 months after int

Interventional group: Who is revising standard alveolar bone grafting with rhBMP-2 injection, the effectiveness of skeletal and dental are examining 4 months after intervention before, as well as imme

Eligibility

Sex/Gender

All

Age

11 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: cleft lip and palate patients; aged over 11 years showing after puberty stage (before CS3) based on cervical vertebral stadium (CVS). Exclusion criteria: Having certain systemic diseases; unwillingness to continue the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Width between canines. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).;First pre-cooled. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).;Volume and density of alveolar bone defects. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).;First permanent molar. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).	—

Measure

Time frame

Width between canines. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).;First pre-cooled. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).;Volume and density of alveolar bone defects. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).;First permanent molar. Timepoint: Before, as well as immediately and 3 months after intervention. Method of measurement: Cone beam computed tomography (CBCT).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahar Irani

Mashhad Faculty of Dentistry

Iraniss921@mums.ac.ir+98 51 3806 7224

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026