Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

NCT06292234 | Not Yet Recruiting

• 1 other identifier: OMFS
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

• Distraction effectiveness

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

  immediate postoperative, 4 months postoperatively, 10 months postoperatively

Secondary Outcomes (8)

• Velopharyngeal insufficiency

  Preoperative , 4 months postoperatively, 10 months postoperatively

• Speech

  preoperative, 4 months postoperatively, and 10 months postoperatively

• Operative time

  Immediate postoperative

• Wound dehiscence

  immediate postoperative till 4 months postoperatively

• Infection

  immediate postoperative till 4 months postoperatively

Study Arms (2)

patient specific implants

EXPERIMENTAL

Custom made designed implants

Device: PSI

miniplates

ACTIVE COMPARATOR

Over the counter miniplates

Device: Conventional miniplates

Interventions

PSI DEVICE

Fabrication of PSI implants using virtual surgical planning

patient specific implants

Conventional miniplates DEVICE

Ready made miniplates

miniplates

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Phd candidate, Department of Oral & Maxillofacial Surgery, Faculty of Dentistry

Model Details: Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 5, 2024
• Study Start: May 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share