Clinical trial of BAMP

JRCT ID: jRCTs022210007

Registered date:02/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: unilateral cleft lip and palate
• Date of first enrollment: 02/06/2021
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Maxillary protraction by anchor plates on maxillary and mandibular bones

Outcome(s)

• Primary Outcome: cephalometric analysis (Wits apprisal)

Secondary Outcome

- cephalometric analysis (except Wits apprisal)
- assessment of facial soft tissue
- assessment of velopharyngeal function
- language assessment

Key inclusion & exclusion criteria

• Age minimum: >= 10age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

- A person who has unilateral cleft lip and palate with skeletal crossbite
- A person who has gone through cheiloplasty, palatoplasty, and alveolar bone graft
- A person who is assessed right after pubertal growth peak through carpal bones

Exclude criteria

- A person who has bilateral cleft lip and palate, cleft lip, cleft palate, and cleft lip and alveolar bone
- A person who has NOT gone through cheiloplasty, palatoplasty, and alveolar bone graft
- A person who has congenital disease with craniofacial anomaly except cleft lip and palate

Related Information

• Primary Sponsor: Igarashi Kaoru