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Cleft PalateNCT07137169

LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

A study testing LIMA protocol and RSCM Protocol in people with Cleft Palate and Fistula of Soft Palate (Disorder), run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 24 months
What is being tested?
LIMA protocol and RSCM Protocol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteIndonesia
Study dates
1 Jan 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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.

Read the detailed description

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.

Being tested
LIMA protocol, RSCM Protocol
Keywords
LIMA Protocol, cleft palate, palatoplasty, cleft palate repair, palatal fistula, maxillary growth restriction
Medical subject headings
Cleft Palate, Retrognathia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIMA protocolProcedure or surgery

    Cleft palate repair using Hybrid / One-flap technique

  • RSCM ProtocolProcedure or surgery

    Cleft palate repair using Two-flap technique

Study groups in NCT07137169
Study groupRoleWhat they receive
LIMA ProtocolExperimentalLIMA Protocol classifies cases of cleft palate based on the cleft severity (using palatal index), and guide which method of cleft palate repair surgery should be done
Receives: Procedure: LIMA protocol
RSCM ProtocolActive comparatorRSCM Protocol guide which method of cleft palate repair surgery should be done in a cleft palate (without classifying based on cleft palate severity/ palatal index)
Receives: Procedure: RSCM Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maxillary Size Indicators Observed From Dental Casts

    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:

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

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

  2. Palatal Fistula by Pittsburgh Classification

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137169
Sponsor's protocol ID
LIMAProtocol
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to concerns regarding patient privacy and confidentiality, as well as institutional policies that limit the sharing of sensitive clinical data without additional ethical approvals and data use agreements

Publications

  • Chiu YT, Liao YF. Is cleft severity related to maxillary growth in patients with unilateral cleft lip and palate? Cleft Palate Craniofac J. 2012 Sep;49(5):535-40. doi: 10.1597/10-044. Epub 2010 Dec 23.

    PubMed 21214323

  • Farronato G, Kairyte L, Giannini L, Galbiati G, Maspero C. How various surgical protocols of the unilateral cleft lip and palate influence the facial growth and possible orthodontic problems? Which is the best timing of lip, palate and alveolus repair? literature review. Stomatologija. 2014;16(2):53-60.

    PubMed 25209227

  • Parwaz MA, Sharma RK, Parashar A, Nanda V, Biswas G, Makkar S. Width of cleft palate and postoperative palatal fistula--do they correlate? J Plast Reconstr Aesthet Surg. 2009 Dec;62(12):1559-63. doi: 10.1016/j.bjps.2008.05.048. Epub 2008 Oct 5.

    PubMed 18838320

  • Rossell-Perry P, Cotrinal-Rabanal O, Caceres-Nano E. One-flap Palatoplasty: A Cohort Study to Evaluate a Technique for Unilateral Cleft Palate Repair. Plast Reconstr Surg Glob Open. 2015 May 7;3(4):e373. doi: 10.1097/GOX.0000000000000342. eCollection 2015 Apr.

    PubMed 25973351

  • Hui BK, Lai LH, Nguyen PD, Yee KS, Martz MG, Bradley JP, et al. Maxillary Hypoplasia in the Cleft Patient: Contribution of Dental Agenesis to Le Fort I Advancement Surgery. Journal of Oral and Maxillofacial Surgery. 2014;72(9):e56-e7.

  • Smith DM, Vecchione L, Jiang S, Ford M, Deleyiannis FW, Haralam MA, Naran S, Worrall CI, Dudas JR, Afifi AM, Marazita ML, Losee JE. The Pittsburgh Fistula Classification System: a standardized scheme for the description of palatal fistulas. Cleft Palate Craniofac J. 2007 Nov;44(6):590-4. doi: 10.1597/06-204.1.

    PubMed 18177198

  • Rossell-Perry P, Caceres Nano E, Gavino-Gutierrez AM. Association between palatal index and cleft palate repair outcomes in patients with complete unilateral cleft lip and palate. JAMA Facial Plast Surg. 2014 May-Jun;16(3):206-10. doi: 10.1001/jamafacial.2013.2537.

    PubMed 24652124

  • Lima Protocol for Cleft Palate Repair in Cleft and Craniofacial Centre Cipto Mangunkusumo Hospital Indonesia: A Preliminary Study. J Plast Rekons. 2024;9(1):7-12.

  • Rossell-Perry P, Cotrina-Rabanal O, Figallo-Hudtwalcker O, Gonzalez-Vereau A. Effect of Relaxing Incisions on the Maxillary Growth after Primary Unilateral Cleft Palate Repair in Mild and Moderate Cases: A Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2017 Jan 16;5(1):e1201. doi: 10.1097/GOX.0000000000001201. eCollection 2017 Jan.

    PubMed 28203502

  • Rossell-Perry P, Luque-Tipula M. The Lima Surgical Protocol for Cleft Palate Repair. J Craniofac Surg. 2020 Sep;31(6):1533-1538. doi: 10.1097/SCS.0000000000006331.

    PubMed 32195838

  • Kreshanti P, Sari VA, Wangge G, Wahyuni LK. Speech Outcome Evaluation Of Cleft Palate Patients Underwent Palatoplasty In Plastic Surgery Division Cipto Mangunkusumo Hospital Indonesia. J Plast Rekonst. 2018;5(1):160-70.

Questions about this trial

What is this clinical trial studying?

A study testing LIMA protocol and RSCM Protocol in people with Cleft Palate and Fistula of Soft Palate (Disorder), run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maxillary Size Indicators Observed From Dental Casts (time frame: From the time of surgery until 6 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07137169, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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