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Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

NCT ID: NCT06292234

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
single blinded clinical trial

Study Groups

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patient specific implants

Custom made designed implants

Group Type EXPERIMENTAL

PSI

Intervention Type DEVICE

Fabrication of PSI implants using virtual surgical planning

miniplates

Over the counter miniplates

Group Type ACTIVE_COMPARATOR

Conventional miniplates

Intervention Type DEVICE

Ready made miniplates

Interventions

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PSI

Fabrication of PSI implants using virtual surgical planning

Intervention Type DEVICE

Conventional miniplates

Ready made miniplates

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Syndromic patients.
2. bone metabolism \& systemic diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hagar Mahmoud Ahmed Mohamed

Principal investigator, Phd candidate, Department of Oral & Maxillofacial Surgery, Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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OMFS

Identifier Type: -

Identifier Source: org_study_id

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