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IRCT20230420057970N1 IRCT 2024-11-04 Combined Militray Hospital 3D plates in mandible fractures RCT Comparison between 3-D Plates and Conventional miniplates in the management of parasymphysis and symphysis fractures of the mandible. 2023-08-17 anticipated 62 Complete https://irct.ir/trial/78522 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups using sealed envelope method. Individuals with odd numbers in the envelopes will be included in Group A and even numbers in Group B. A third person not being part of the study will open the envelopes and the patients will be allocated to the mentioned groups, Blinding description: Patients were blinded as they were not informed about the treatment modality used for management of their ailment, but consent was taken. An independent assessor, who will be a senior and experienced Oral and Maxillofacial Surgeon and will not be part of the study, will assess patients, he will also be blinded. N/A Fracture of mandible.. Intervention 1: Intervention group: Group A: Mandible fractures will be fixated with 3D plates according to Champys lines of Osteosynthesis. All cases will be treated under strict aseptic conditions, general anesthesia and local anesthesia ( 1.8ml 2% Lignocaine with Adrenaline 1:100,000;Septodont, USA) given in fracture vicinity by a single surgical team. Temporary MMF will be done using eyelets and tie wires (prestretched, round, stainless steel, 24 gauge, 6 inches in length) to achieve best possible occlusion. One titanium 3-D plates, square shaped 4 hole, 2mm thick [Grade 4] (Moin International CE, Pakistan) will be adapted and secured with the help of titanium monocortical screws [Grade 5] around the fracture line in the subapical region. 7mm length screws will be inserted in upper holes and 9mm in lower hole. Muscle and then mucosal closure will be done with vicryl 3.0 (Ethicon, USA) respectively. All patients will be prescribed I/V pre-op broad spectrum antibiotics (Inj I/V Augmentine 1.2g BD, Inj I/V Flagyl 500mg BD) which will be continued post-op along with analgesics (Inj I/V Toradol 30mg TDS), antiemetic (Inj I/V Maxalon 10mg STAT) and fluids (Inf I/V Ringer Lactate + 5% Dextrose over 24 hrs) for 3 days according to the ward protocol. Post-op MMF will only be done if occlusion is not statsfactory. Patient will be advised liquid diet and strict oral hygiene instructions (intraoral irrigation and suctioning, 24 hours after the procedure with Enziclor (0.15% Benzydamine Hydrochorlide/ 0.2% Chlorhexidine Gluconate)( Platinum Pharmacueticals Pvt Ltd, Pakistan) 3 times a day, after meals. Intervention 2: Control group: Group B: Mandible fractures will be Fixated with conventional mini plates According to Champys line of Osteosynthesis. All cases will be treated under strict aseptic conditions, general anesthesia and local anesthesia (1.8ml 2% Lignocaine with Adrenaline 1:100,000;Septodont, USA) given in fracture vicinity by a single surgical team. Temporary MMF will be done using eyelets and tie wires (prestretched, round, stainless steel, 24 gauge, 6 inches in length) to achieve best possible occlusion. Conventional titanium miniplates (Moin International CE, Pakistan); one 4/5 hole[Grade 5] in subapical region with 7mm [Grade 4] screws and 5/6 hole [Grade 5] in inferior boarder region with 9mm screws [Grade4] will be adapted and secured. Number of hole can Increase as per obliqueness of fracture line. Muscle and then mucosal closure will be done with vicryl 3.0 (Ethicon, USA) respectively. All patients will be prescribed I/V pre-op broad spectrum antibiotics (Inj I/V Augmentine 1.2g BD, Inj I/V Flagyl 500mg BD) which will be continued post-op along with analgesics (Inj I/V Toradol 30mg TDS), antiemetic (Inj I/V Maxalon 10mg STAT) and fluids for 3 days (Inf I/V Ringer Lactate + 5% Dextrose over 24 hrs) according to the ward protocol. Post-op MMF will only be done if per-op stability of the fractured segments is not achieved. Patient will be advised liquid diet and strict oral hygiene instructions (intraoral irrigation and suctioning, 24 hours after the procedure with Enziclor (0.15% Benzydamine Hydrochorlide/ 0.2% Chlorhexidine Gluconate)( Platinum Pharmacueticals Pvt Ltd, Pakistan) 3 times a day after meals. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Lt. Col Muhammad Chaudry Usman
2G3R+9W5, Mall Rd, Peshawar Cantonment
Peshawar Pakistan 25000 +92 348 3488043 usman.chy@gmail.com Combined Military Hospital scientific Aminah Khan
House#494, Main Road, Gulber# 2
Peshawar Pakistan 25000 +92 333 6545366 aminahkhan93@gmail.com Combined Military Hospital Pakistan Pain following history of fall/ RTA/ trauma Age 18-50 years American Society of Anesthesiologist ASA Class 1 Isolated mandible fractures 18 years 50 years Both Infection at site of fracture Comminuted fractures Panfacial trauma Patients with a bone pathology (osteomyelitis, osteoporosis and paget’s Disease) Chronic Illness (uncontrolled diabetes, asthma and hypertension) S02.6 Fracture of mandible Treatment - Devices Treatment - Devices Intervention group: Group A: Mandible fractures will be fixated with 3D plates according to Champys lines of Osteosynthesis. All cases will be treated under strict aseptic conditions, general anesthesia and local anesthesia ( 1.8ml 2% Lignocaine with Adrenaline 1:100,000;Septodont, USA) given in fracture vicinity by a single surgical team. Temporary MMF will be done using eyelets and tie wires (prestretched, round, stainless steel, 24 gauge, 6 inches in length) to achieve best possible occlusion. One titanium 3-D plates, square shaped 4 hole, 2mm thick [Grade 4] (Moin International CE, Pakistan) will be adapted and secured with the help of titanium monocortical screws [Grade 5] around the fracture line in the subapical region. 7mm length screws will be inserted in upper holes and 9mm in lower hole. Muscle and then mucosal closure will be done with vicryl 3.0 (Ethicon, USA) respectively. All patients will be prescribed I/V pre-op broad spectrum antibiotics (Inj I/V Augmentine 1.2g BD, Inj I/V Flagyl 500mg BD) which will be continued post-op along with analgesics (Inj I/V Toradol 30mg TDS), antiemetic (Inj I/V Maxalon 10mg STAT) and fluids (Inf I/V Ringer Lactate + 5% Dextrose over 24 hrs) for 3 days according to the ward protocol. Post-op MMF will only be done if occlusion is not statsfactory. Patient will be advised liquid diet and strict oral hygiene instructions (intraoral irrigation and suctioning, 24 hours after the procedure with Enziclor (0.15% Benzydamine Hydrochorlide/ 0.2% Chlorhexidine Gluconate)( Platinum Pharmacueticals Pvt Ltd, Pakistan) 3 times a day, after meals. Control group: Group B: Mandible fractures will be Fixated with conventional mini plates According to Champys line of Osteosynthesis. All cases will be treated under strict aseptic conditions, general anesthesia and local anesthesia (1.8ml 2% Lignocaine with Adrenaline 1:100,000;Septodont, USA) given in fracture vicinity by a single surgical team. Temporary MMF will be done using eyelets and tie wires (prestretched, round, stainless steel, 24 gauge, 6 inches in length) to achieve best possible occlusion. Conventional titanium miniplates (Moin International CE, Pakistan); one 4/5 hole[Grade 5] in subapical region with 7mm [Grade 4] screws and 5/6 hole [Grade 5] in inferior boarder region with 9mm screws [Grade4] will be adapted and secured. Number of hole can Increase as per obliqueness of fracture line. Muscle and then mucosal closure will be done with vicryl 3.0 (Ethicon, USA) respectively. All patients will be prescribed I/V pre-op broad spectrum antibiotics (Inj I/V Augmentine 1.2g BD, Inj I/V Flagyl 500mg BD) which will be continued post-op along with analgesics (Inj I/V Toradol 30mg TDS), antiemetic (Inj I/V Maxalon 10mg STAT) and fluids for 3 days (Inf I/V Ringer Lactate + 5% Dextrose over 24 hrs) according to the ward protocol. Post-op MMF will only be done if per-op stability of the fractured segments is not achieved. Patient will be advised liquid diet and strict oral hygiene instructions (intraoral irrigation and suctioning, 24 hours after the procedure with Enziclor (0.15% Benzydamine Hydrochorlide/ 0.2% Chlorhexidine Gluconate)( Platinum Pharmacueticals Pvt Ltd, Pakistan) 3 times a day after meals. Stability will be checked between both the plating systems. Timepoint: Just after plate Insertion, 1 week, 4 weeks. Method of measurement: Checked clinically by manual manipulation to assess mobility of fractured segments post-op after fixation. Malocclusion. Timepoint: 1st post op day, 1week, 4 week. Method of measurement: Deflection from the normal relation or alignment of the teeth to other teeth in the same arch and/or to the teeth in the opposing arch, 2mm or more space between maxillary and mandibular teeth. Post op pain. Timepoint: 1st post op day, 1 week, 4 week. Method of measurement: Evaluated by Visual analog scale. Wound Dehisence. Timepoint: 1st post op day, 1 week, 4 week. Method of measurement: Plate exposure and visibility in the oral cavity. Combined Militray Hospital Approved 2022-04-29 Ethical Review Committee for Dental Research, 30 MDC 2G3R+9W5, Mall Rd, 30 MDC, Peshawar Cantonment Peshawar Khyber Pakhtun Khawa Pakistan