Occlusal Assessment of Pediatric Mandibular Fractures Man... | NCT07515937

Studies
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series

NCT07515937

Sponsor

Cairo University

Status

Recruiting

Last Update Posted

Apr 7, 2026Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Pediatric Mandibular Fracture

Interventions

3D-printed occlusal cap splint

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Jul 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Apr 2, 2026

First Posted Date

Apr 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is conducted to evaluate the accuracy of 3D-printed acrylic occlusal cap splint fabricated by computer-guided software in reduction and fixation of pediatric mandibular fractures. There are a wide range of choices in the management of mandibular pediatric trauma, ranging from observation and follow-up, conservative treatment, and open reduction and internal fixation (ORIF).

Mandibular growth, with the presence of tooth buds, along with deciduous/ permanent teeth eruption (mixed dentition) favor the use of conservative approaches in the management of pediatric mandibular fractures, where splints are fixed over the mandible by the use of circum-mandibular wiring (non-rigid fixation). The virtual surgical planning is increasing in popularity in craniomaxillofacial surgery.

There are multiple advantages that this study offers. First, it is suitable for the patients with a complete primary dentition as well as those in mixed dentition. Second, the fracture segments will be reduced accurately during virtual surgical simulation, improving the accuracy of the operation. Third, due to the splint is done according to the individual dentition of the child, it is more stable than the traditional dental arch splint ligation. Fourth, compared with intraoperative impression taking, pouring them into casts, fracturing and reattaching them in the correct positions to fabricate the splints, it avoids the contamination of the operation area and helps shorten the operation's time spent, and improves the safety and efficiency of the operation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment by 3D-printed occlusal cap splint	Experimental		Device: 3D-printed occlusal cap splint

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D-printed occlusal cap splint	Device	Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures	Treatment by 3D-printed occlusal cap splint

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occlusion	Occlusion will be assessed to be satisfactory or not, according to Angle classification, absence of midline shift, cross-bite or open-bite.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Radiographic evidence of fracture reduction	Radiographic evidence of fracture reduction will be assessed by panoramic radiograph.	3 months
Maximum mouth opening	Maximum mouth opening will be assessed in millimeters using a ruler

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients in the mixed dentition phase, aged from 6 to 12 years, with no gender predilection.
Recent fracture.
Single line of fracture; symphyseal, parasymphyseal or body fracture.

Exclusion Criteria:

Patients with systemic diseases that may impair bone repair.
Patients with more than one line of fracture.
Patients with pan-facial, ramus, or condylar fractures.
Patients with comminuted mandibular fractures.
Patients with infection or pre-existing mandibular pathology at the fracture site.
Patients who are unable to tolerate follow-up intervals.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University	Recruiting	Cairo	Cairo Governorate		Egypt