Egypt faculty of dentistry, tanta university
Tanta, Egypt
NCT Number: NCT07206134
Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Virtual surgical planning and 3D printing technology were used to fabricate customized plates in Group I. Clinical and radiographic assessments were conducted immediately, at 1 week, 3 months, and 6 months postoperatively. Parameters evaluated included soft tissue healing, pain, facial edema, lower lip paresthesia, maximal mouth opening, occlusion, fracture stability, and hardware integrity.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Tanta, Egypt
This study was conducted on twelve adult patients with mandibular fracture in mental nerve region, selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
The selected patients were randomly divided into two equal groups, group I (6 patients) were treated by modified omega bone plate, while group II (6 patients) were treated by 2.0 mm conventional miniplates according to Champy's principle. A comparison between the two groups was conducted.
Modified Omega bone plate is a specially-designed, 8-hole, titanium miniplate modified by adding upper struts to the Ω symbol. It has lower horizontal struts (which provides stability along the lower border) with four holes, the proximal 2 holes are round and the distal are pear shape (compression holes). Two vertical struts at the ends of the horizontal struts (which provide resistance against the torsional forces),Upper horizontal struts (which counteract the tensional forces along the alveolar border) with four holes the proximal 2 holes are round and the distal are pear shape. The omega shape of this plate helps it to adapt easily around the mental neurovascular bundle.
Preoperative evaluation of the patients was carried out by taking history and performing clinical and radiographic examinations. Clinical examination included intraoral and extraoral inspection and palpation of the fracture sites. Radiographic examination was used to determine the site, number, type of fractures and degree of displacement.
Under general anesthesia, the fracture line was exposed through an intraoral approach, and the fracture segments were reduced. In group I, fixation of the reduced segments was done with modified omega bone plate which predetermined virtually. In group II, 2conventional miniplates placed on inferior border & subapical were used to fix the fracture.
Postoperative clinical evaluation were performed immediately, one week, two weeks, one month, three months and postoperative radiographic evaluation were performed immediately, three months and six months. The postoperative clinical evaluation included presence or absence of infection, bony union or stability, state of occlusion, maximal mouth opening, sensory nerve function, condition of teeth related to the fracture line and, patient's tolerance to the plate.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region
Indicated for open reduction and internal fixation (ORIF)
Exclusion criteria
Reflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate
Reflection of vestibular flap with dissection around mental bundle and fracture reduction and fixation with 2 miniplates
Time frame: At 1 day, 3 days, 1 week, and 1 month postoperatively
Pain will be assessed using a 10-cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: At 1 day, 3 days, 1 week
Edema will be assessed utilizing a horizontal and vertical guide with a tape on four reference points: outer canthus of the eye, angle of the mandible, tragus of the ear and outer corner of the mouth respectively. To obtain the percentage of facial swelling, the difference between measurements of the postoperative and preoperative periods will be divided by the value of the preoperative period.
Souza JA, Consone DP. Method for measurement of facial edema after oral surgery.
Time frame: Up to 3 months
Sensory function tested using caliber
Time frame: Preoperative, and postoperative day 1, day 3, 1 week, and 1 month
Measured using digital caliper between maxillary and mandibular central incisors.
Time frame: Postoperative 1 week and 1 month
Clinical evaluation of occlusion compared with pre-injury status using ulgics questionnaire
Time frame: Intraoperative
Total duration of surgery measured from first incision to last suture.
Time frame: 1 day Postoperative
Linear measurement radiographically on immediate postoperative CT
Tanta University
Other
Modified Omega Bone Plate Versus Conventional Miniplates for Fixation of Mandibular Fractures in Mental Nerve Region
Acronym: COMET-OMF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07736430
Craniocerebral Trauma, Facial Injuries
Ismailia, Egypt
View Trial DetailsNCT07245758
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Charleston, South Carolina, United States
View Trial DetailsNCT06392204
Craniocerebral Trauma, Facial Injuries
Cairo, Egypt
View Trial DetailsNCT07153120
Craniocerebral Trauma, Facial Injuries
Al Mansurah, Egypt
View Trial Details