Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Device: PSI; Device: Conventional miniplates

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient specific implants; Custom made designed implants	Device: PSI; Fabrication of PSI implants using virtual surgical planning
Active Comparator: miniplates; Over the counter miniplates	Device: Conventional miniplates; Ready made miniplates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distraction effectiveness	Amount of distraction using Lateral Cephalometry & FBCT measured in millimeters (mm)	immediate postoperative, 4 months postoperatively, 10 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Measuring the time of the procedures in minutes	Immediate postoperative
Velopharyngeal insufficiency	Scoring from 0 to 4; 0: Normal, 1: minimal, 2: mild, 3: moderate, 4: sever using endoscopy	Preoperative , 4 months postoperatively, 10 months postoperatively
Speech	Nasometry Speech assessment; 1=absent, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.	preoperative, 4 months postoperatively, and 10 months postoperatively
Wound dehiscence	Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Infection	Clinical assessment of presence or absence of infection (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Nerve affection	Clinical assessment of presence or absence of nerve affection (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Screw loosening	Clinical assessment of presence or absence of screw loosening (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Overall complications	Clinical assessment of presence or absence of complications (Binary: Yes or No)	immediate postoperative, 4 months postoperatively and 10 months postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: OMFS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No