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Cleft Lip and PalateNCT06292234

Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

A study testing PSI and Conventional miniplates in people with Cleft Lip and Palate, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue \& better long-term stability \& less relapse rate. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Cleft Lip and Palate
What is being tested?
PSI and Conventional miniplates
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 May 2024to 1 Mar 2025
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 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Non growing cleft patients, age range (18-30 years)
  • Unilateral or bilateral cleft patients
  • Anteroposterior deficiency (1.5-2.5 cm)
  • No sex predilection

Who cannot join

  • Syndromic patients.
  • bone metabolism \& systemic diseases.

About this study

Official title: External Distraction Using Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla in Non-growing Cleft Patients

Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue \& better long-term stability \& less relapse rate.

Read the detailed description

Maxillary distraction using rigid external distraction device (RED) with skeletal anchorage in cleft lip and palate overcomes the disadvantages of tooth brone RED \& showed reliable advancement \& reasonable relapse rate in the short \& long-term follow up \& most importantly it solved somehow counterclockwise rotation of maxilla but still it can occur. Positioning of plates in relation to center of resistance of maxilla to adjust vector of distraction can be done now by using Virtual surgical planning (VSP) \& fabrication of patient specific implants (PSI) to overcome problems encountered with use of conventional miniplates during distraction process. Limited data in literature with no randomized clinical trials were done to assess distraction effectiveness using PSI in RED with skeletal anchorage and its effect on velopharyngeal insufficiency (VPI) \& speech. Based on that data, the research will compare distraction effectiveness, VPI \& speech between using either PSI implants or miniplates for distraction.

Being tested
PSI, Conventional miniplates
Medical subject headings
Cleft Lip

What participants receive

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

  • PSIDevice

    Fabrication of PSI implants using virtual surgical planning

  • Conventional miniplatesDevice

    Ready made miniplates

Study groups in NCT06292234
Study groupRoleWhat they receive
patient specific implantsExperimentalCustom made designed implants
Receives: Device: PSI
miniplatesActive comparatorOver the counter miniplates
Receives: Device: Conventional miniplates

What is being measured

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

  1. Distraction effectiveness

    Amount of distraction using Lateral Cephalometry \& FBCT measured in millimeters (mm)

    Measured: immediate postoperative, 4 months postoperatively, 10 months postoperatively

Secondary outcomes (8)

  1. Velopharyngeal insufficiency

    Scoring from 0 to 4; 0: Normal, 1: minimal, 2: mild, 3: moderate, 4: sever using endoscopy

    Measured: Preoperative , 4 months postoperatively, 10 months postoperatively

  2. Speech

    Nasometry Speech assessment; 1=absent, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.

    Measured: preoperative, 4 months postoperatively, and 10 months postoperatively

  3. Operative time

    Measuring the time of the procedures in minutes

    Measured: Immediate postoperative

  4. Wound dehiscence

    Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No)

    Measured: immediate postoperative till 4 months postoperatively

  5. Infection

    Clinical assessment of presence or absence of infection (Binary: Yes or No)

    Measured: immediate postoperative till 4 months postoperatively

  6. Nerve affection

    Clinical assessment of presence or absence of nerve affection (Binary: Yes or No)

    Measured: immediate postoperative till 4 months postoperatively

  7. Screw loosening

    Clinical assessment of presence or absence of screw loosening (Binary: Yes or No)

    Measured: immediate postoperative till 4 months postoperatively

  8. Overall complications

    Clinical assessment of presence or absence of complications (Binary: Yes or No)

    Measured: immediate postoperative, 4 months postoperatively and 10 months postoperatively

Timeline

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

  1. First posted5 Mar 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

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
Model description
Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292234
Sponsor's protocol ID
OMFS
Status last verified
Apr 2024
First submitted
25 Feb 2024
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PSI and Conventional miniplates in people with Cleft Lip and Palate, run by Cairo University.

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 4 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Distraction effectiveness (time frame: immediate postoperative, 4 months postoperatively, 10 months postoperatively). 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 NCT06292234.

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 19 Apr 2024.

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