Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292234
• Other study ID #: OMFS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• PSI
Fabrication of PSI implants using virtual surgical planning
• Conventional miniplates
Ready made miniplates

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distraction effectiveness	Amount of distraction using Lateral Cephalometry & FBCT measured in millimeters (mm)	immediate postoperative, 4 months postoperatively, 10 months postoperatively
Secondary	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
Secondary	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
Secondary	Operative time	Measuring the time of the procedures in minutes	Immediate postoperative
Secondary	Wound dehiscence	Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Secondary	Infection	Clinical assessment of presence or absence of infection (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Secondary	Nerve affection	Clinical assessment of presence or absence of nerve affection (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Secondary	Screw loosening	Clinical assessment of presence or absence of screw loosening (Binary: Yes or No)	immediate postoperative till 4 months postoperatively
Secondary	Overall complications	Clinical assessment of presence or absence of complications (Binary: Yes or No)	immediate postoperative, 4 months postoperatively and 10 months postoperatively