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NCT Number: NCT07137169

LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

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.

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Fistula of Soft Palate (Disorder) Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillar Hypoplasia Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

9 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

Background: Palatoplasty in patients with cleft palate carries risks of palatal fistula and impaired maxillary growth, both of which are influenced by cleft severity and surgical technique. The LIMA protocol offers a refined classification and tailored surgical approach, with promising results in reducing these complications.

Methods: This study is a randomized controlled trial comparing palatoplasty techniques based on the LIMA protocol (Hybrid and one-flap techniques) versus the RSCM protocol (two-flap technique) in terms of surgical outcomes: palatal fistula and maxillary growth. The study was conducted at Cipto Mangunkusumo Hospital (RSCM) from January 2022 to December 2024. Samples were collected consecutively, with all subjects who met the inclusion criteria (patients aged 9 months-2 years with unilateral Veau III-IV cleft palate undergoing primary palatoplasty at RSCM) randomly allocated into two study groups. Data were analyzed using T-test and Mann-Whitney U test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIMA protocol

Procedure

Cleft palate repair using Hybrid / One-flap technique

RSCM Protocol

Procedure

Cleft palate repair using Two-flap technique

Primary outcomes

  1. Maxillary Size Indicators Observed From Dental Casts

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

    Maxillary growth is assessed by measuring its size based on indicators obtained from dental casts before surgery, 1 month post-surgery, and 6 months post-surgery.

    There will be 4 indicators, namely:

    • 'CC = primary inter-canine width
    • 'TT = inter-tuberosity width
    • 'ICC = length from incisivus to the 'CC line (indicating anterior palatal length)
    • 'ITT = length from incisivus to the 'TT line (indicating overall palatal length)

  2. Palatal Fistula by Pittsburgh Classification

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

    A palatal fistula is an abnormal opening in the palate that persists or develops after cleft palate repair, creating a connection between the oral and nasal cavities, excluding openings due to wound/ suture dehiscence.

    The location of opening will be Classified using Pittsburgh Classification;

    Type I: uvula; Type II: soft palate; Type III: junction between the soft and hard palate; Type IV: hard palate; Type V: junction between the primary and secondary palate; Type VI: lingual-alveolar; Type VII: labial-alveolar.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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