Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial
Sponsor study identifier
interventional
20
1 country
1
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical \& functional restoration with reduced operative time in mandibular fracture,
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2025
Actual (reported)December 4, 2025
Actual (reported)January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Radiographic evaluation
* The linear inter-fragmentary gap between the fractured segments in mm * Intergonial distance was measured between the most inferior, lateral, and posterior points of the mandible bilaterally as determined on CT in mm.
24 hour after surgery and after 3 months
Mobility of fracture segments
assessed through bimanual digital manipulation * Stable \>\> no movement of fragments. * Nonstable \>\> presence of movement.
24 hour after surgery
State of occlusion
will be assessed by asking the patient to bite in maximum intercuspation at each follow-up (intact/deranged) also by recording molar relation as (satisfactory or deranged).
after 24 hours and after 3 months of surgery
site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.).
site with mandibular fracture will be reduced and fixation will be done .visibility using conventional double-mini plates in Group II and fixation using 2 mini-plates according to champ's lines of osteo-synthesis in Group II.
site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mataria Teaching Hospital
Cairo, 2211, Egypt
Saad, A., Khalil, A. F., & El-Mahallawy, Y. (2025). INTERFLEX PLATE VERSUS CONVENTIONAL MINIPLATES IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURES. a RANDOMIZED CONTROLLED CLINICAL TRIAL. Alexandria Dental Journal, 0(0), 0. https://doi.org/10.21608/adjalexu.2025.344361.1572
Mohamed Ah Elsholukamy, Professor
Suez Canal University
Mohamed Na Gad Elhaq, lecturer
Suez Canal University
Maurice Fe khalil, consultant
Mataria Teaching Hospital
First Submitted
November 16, 2025
First Posted
Contact the study team to confirm eligibility.
December 4, 2025
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 22, 2026
Record last verified: 2025-11
because these are patient data that cant be shared
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: