CompletedNot Applicable

LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

Indonesia35 participantsStarted 2022-01-01

Plain-language summary

This randomized controlled trial compared palatoplasty outcomes using the LIMA protocol (Hybrid and one-flap techniques) versus the RSCM protocol (two-flap technique) in patients with unilateral Veau III-IV cleft palate at Cipto Mangunkusumo Hospital from January 2022 to December 2024.

Who can participate

Age range9 Months – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with complete unilateral cleft lip and palate aged 9 months to 2 years who agreed to be research subjects * Patients with complete unilateral cleft lip and palate who underwent palatoplasty surgery at Cipto Mangunkusumo Hospital Exclusion Criteria: * Patients who refuse to be research subjects and do not want to sign consent form * Patients with complete unilateral cleft lip and palate who have previously undergone cleft palate repair/ palatoplasty

What they're measuring

Maxillary Size Indicators Observed From Dental Casts

Timeframe: From the time of surgery until 6 months post-operatively

Palatal Fistula by Pittsburgh Classification

Timeframe: From the time of surgery until 6 months post-operatively

Trial details

NCT IDNCT07137169

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Cleft Palate trials