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LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

NCT07137169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-22

No results posted yet for this study

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.

Conditions

  • Cleft Palate
  • Fistula of Soft Palate (Disorder)
  • Maxillar Hypoplasia

Interventions

PROCEDURE

LIMA protocol

Cleft palate repair using Hybrid / One-flap technique

PROCEDURE

RSCM Protocol

Cleft palate repair using Two-flap technique

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137169 on ClinicalTrials.gov