Study of the phenytoin spray using effects in prevention of fistula after cleft palate surgery in children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180802040678N3

Enrollment

Registered

2019-09-16

Start date

2010-03-01

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Cleft Palate. Cleft hard palate with cleft soft palate

Interventions

Intervention 1: Intervention group: Administration of phenytoin spray 2% severy four hours for eight weeks. Intervention 2: Control group: Receiving nothing.

Eligibility

Sex/Gender

All

Age

No minimum to 15 Years

Inclusion criteria

Inclusion criteria: Having a combined hard and soft palate Aged between 2 months to 2 years old

Exclusion criteria

Exclusion criteria: Revision surgery of cleft palate Soft palate cleft only Atypical Cleft Past medical history of seizure and systemic diseases Using anti convulsant, anti hypertension, and immune suppressant drugs

Design outcomes

Primary

Measure	Time frame
Fistula Formation. Timepoint: After eight weeks. Method of measurement: Physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Nouri-Vaskeh

Tabriz University of Medical Sciences

mnvaske@gmail.com+98 41 3325 9778

Outcome results

None listed

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