Comparison between 3D delta plate and conventional miniplate in treatment of condylar fracture: A randomised clinical trial |
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| Affiliation: | 1. Nankai University, Tianjin, 300071, China;2. Tianjin Stomatological Hospital, School of Medicine, Nankai University, Tianjin Key Laboratory of Oral and Maxillofacial Function Reconstruction, Tianjin 300041, China;1. Department of Plastic and Reconstructive Surgery, Xiangya III Hospital of Central South University, 138 tongzipo Road, 410000, Changsha City, People’s Republic of China;2. Department of Plastic and Reconstructive Surgery, Shanghai Ninth People''s Hospital, Shanghai JiaoTong University School of Medicine, China;3. The College of Cedical Instrument, Shanghai University of Medicine & Health Sciences, No.257 Zhouzhu Highway, Pudong District, Shanghai, China;4. Department of Oral and Craniofacial Science, Shanghai Ninth People''s Hospital, Shanghai Jiao Tong University School of Medicine, China;5. Department of Plastic and Reconstructive Surgery, Maternal and Child Health Care Hospital of Hainan Province, Haikou, 570206, China;1. Department of Pediatric Cranio-Maxillo-Facial Surgery, Hôpital Femme Mère Enfant, 59 Boulevard Pinel, 69677, Bron, France;2. Department of Cranio-Maxillo-Facial Surgery, Centre Hospitalo-Universitaire Nord, Avenue Albert Raimond, 42000, Saint-Etienne, France;3. Université Jean Monnet, 6 Rue Basse des Rives, 42100, Saint-Étienne, France;4. Department of Pediatric Neurosurgery, Hôpital Femme Mère Enfant, 59 Boulevard Pinel, 69677, Bron, France;5. Université Claude Bernard Lyon 1, 43 Boulevard Du 11 Novembre 1918, 69100, Villeurbanne, France;1. Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged, Department of Oral and Maxillofacial Surgery and Otolaryngology, Nyíri út 38, Kecskemét, Hungary;2. Doctoral School of Clinical Medicine, University of Szeged, Kálvária Sugárút 57, Szeged, Hungary;3. Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Faculty of Medicine, University of Szeged, Kálvária Sugárút 57, Szeged, Hungary;4. Multidisciplinary Head and Neck Cancer Center, National Institute of Oncology, Ráth György Utca 7-9, Budapest, Hungary |
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| Abstract: | The aim of the study was to conduct a randomized clinical trial comparing the efficacy of standard non-compression miniplate and 3-dimensional (3D) titanium plate in the open reduction internal fixation (ORIF) of the mandibular condylar fractures.Patients who underwent open reduction of mandibular condylar fracture were recruited for the study. The patients satisfying the inclusion criteria were randomly assigned to two groups in a 1:1 ratio. Group A comprised patients treated using conventional miniplates, and Group B comprised patients treated using 3D Delta Plate. Informed consent was provided. All the patients underwent ORIF under GA via retromandibular approach.The sample size was set at 20 participants, with 10 participants in each group who were randomly allocated. Our study showed that patients in Group A had a significant statistical difference operating time (141.20 ± 2.59 min) than that of Group B (117.2 ± 9.63 min). Mouth opening was significantly greater in the 3rd-month follow-up in Group B (mean = 42.40 ± 1.82) compared to Group A (mean = 35.80 ± 1.30). Biting efficiency in Group B was observed to be clinically and statistically better compared to Group A (P = 0.012). Wound dehiscence was managed efficiently by judicious use of antibiotics and wounds were free of any signs of infections or discharge in the consecutive follow-ups. No plate removal was required in either group.Patients treated with 3D delta plates have superior outcomes with regard to operation time, mouth opening, and biting efficiency compared with miniplates. Hence, it can be concluded that the triangular shape of the 3D Delta plate allows the stress distribution to be superior and multidimensional, leading to better post-operative stability, faster healing, and reduced complications. |
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| Keywords: | Miniplates 3D delta plates Retromandibular incision Open reduction internal fixation (ORIF) Malocclusion Mandibular condylar fracture |
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