Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar

Maxillofacial Injuries Clinical Trial

Official title:

Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05801328
• Other study ID #: USM/JEPeM/22110704
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: Universiti Sains Malaysia
• Contact: NG Kar Tsyeng, BDS
• Phone: 0165216351
• Email: kartsyeng86[@]Hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with jaw fractures requires placement of Erich arch bar for immobilization of the fractured jaw. However, the usage of Erich arch bar is associated with an increased in the incidence of mucosal trauma and plaque accumulation. Conventionally, the ends of the wires has always been placed apical to the teeth.

This study aims to determine if a change in the placement of the wire by directing it to the occlusal direction will reduce the incidence of mucosal trauma, plaque accumulation and if the stability of the Erich arch bar will be affected by this intervention.

The patients' teeth will be divided into left and right side and randomized into control side (wires end apically) and interventional side (wires end occlusally)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18 years - 60 years old.

• Full Glasgow coma scale.

• Facial fractures requiring Erich arch bar for 4 weeks duration

• No functional deficit that will prevent tooth brushing.

Exclusion Criteria:

• All pathologic fractures due to cysts, tumors, and cancers

• Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)

Related Conditions & MeSH terms

• Maxillofacial Injuries

Intervention

Device:
• Ending of the wires on Erich arch bar in the occlusal direction
The wires of the Erich arch bar will be placed on the occlusal direction

Locations

Country	Name	City	State
Malaysia	Universiti Sains Malaysia	Kota Bharu	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (24)

Adeyemo WL, Ladeinde AL, Ogunlewe MO, James O. Trends and characteristics of oral and maxillofacial injuries in Nigeria: a review of the literature. Head Face Med. 2005 Oct 4;1:7. doi: 10.1186/1746-160X-1-7. — View Citation

Bali R, Sharma P, Garg A. Incidence and patterns of needlestick injuries during intermaxillary fixation. Br J Oral Maxillofac Surg. 2011 Apr;49(3):221-4. doi: 10.1016/j.bjoms.2010.04.010. Epub 2010 May 21. — View Citation

de Queiroz SB. Modification of arch bars used for intermaxillary fixation in oral and maxillofacial surgery. Int J Oral Maxillofac Surg. 2013 Apr;42(4):481-2. doi: 10.1016/j.ijom.2012.11.003. Epub 2012 Dec 12. — View Citation

Farber SJ, Snyder-Warwick AK, Skolnick GB, Woo AS, Patel KB. Maxillomandibular Fixation by Plastic Surgeons: Cost Analysis and Utilization of Resources. Ann Plast Surg. 2016 Sep;77(3):305-7. doi: 10.1097/SAP.0000000000000592. — View Citation

Fasoulas A, Pavlidou E, Petridis D, Mantzorou M, Seroglou K, Giaginis C. Detection of dental plaque with disclosing agents in the context of preventive oral hygiene training programs. Heliyon. 2019 Jul 10;5(7):e02064. doi: 10.1016/j.heliyon.2019.e02064. eCollection 2019 Jul. — View Citation

Fernandes IA, Lopes ABS, Fonseca PG, da Silva Torres A, Rodrigues AB, Galvao EL, Falci SGM. Comparison between Erich arch bars and intermaxillary screws in maxillofacial fractures involving the dental occlusion: a meta-analysis. Int J Oral Maxillofac Surg. 2021 Jan;50(1):83-95. doi: 10.1016/j.ijom.2020.07.022. Epub 2020 Aug 12. — View Citation

Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9. — View Citation

Gilardino MS, Chen E, Bartlett SP. Choice of internal rigid fixation materials in the treatment of facial fractures. Craniomaxillofac Trauma Reconstr. 2009 Mar;2(1):49-60. doi: 10.1055/s-0029-1202591. No abstract available. — View Citation

Haggard P, de Boer L. Oral somatosensory awareness. Neurosci Biobehav Rev. 2014 Nov;47:469-84. doi: 10.1016/j.neubiorev.2014.09.015. Epub 2014 Oct 2. — View Citation

Hamid ST, Bede SY. The Use of Screw Retained Hybrid Arch Bar for Maxillomandibular Fixation in the Treatment of Mandibular Fractures: A Comparative Study. Ann Maxillofac Surg. 2021 Jul-Dec;11(2):247-252. doi: 10.4103/ams.ams_35_21. Epub 2022 Feb 1. — View Citation

Jain A, Taneja S, Rai A. What is a better modality of maxillomandibular fixation: bone-supported arch bars or Erich arch bars? A systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2021 Oct;59(8):858-866. doi: 10.1016/j.bjoms.2021.01.004. Epub 2021 Jan 18. — View Citation

Kaura S, Kaur P, Bahl R, Bansal S, Sangha P. Retrospective Study of Facial Fractures. Ann Maxillofac Surg. 2018 Jan-Jun;8(1):78-82. doi: 10.4103/ams.ams_73_17. — View Citation

Kirk D, Whitney J, Shafer D, Song L. Tight Placement of Erich Arch Bar While Avoiding Wire Fatigue Failure. J Oral Maxillofac Surg. 2016 Mar;74(3):562-8. doi: 10.1016/j.joms.2015.10.008. Epub 2015 Oct 19. — View Citation

Koshy JC, Feldman EM, Chike-Obi CJ, Bullocks JM. Pearls of mandibular trauma management. Semin Plast Surg. 2010 Nov;24(4):357-74. doi: 10.1055/s-0030-1269765. — View Citation

Loe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000 Jun;50(3):129-39. doi: 10.1111/j.1875-595x.2000.tb00553.x. — View Citation

Pedemonte C, Valenzuela K, Gonzalez LE, Vargas I, Noguera A. Types of Intermaxillary Fixation and Their Interaction With Palatine Fracture Reduction. J Oral Maxillofac Surg. 2019 Oct;77(10):2083.e1-2083.e8. doi: 10.1016/j.joms.2019.06.006. Epub 2019 Jun 21. — View Citation

Qureshi AA, Reddy UK, Warad NM, Badal S, Jamadar AA, Qurishi N. Intermaxillary fixation screws versus Erich arch bars in mandibular fractures: A comparative study and review of literature. Ann Maxillofac Surg. 2016 Jan-Jun;6(1):25-30. doi: 10.4103/2231-0746.186129. — View Citation

Rai A, Jain A, Datarkar A, Bhawalkar A. Use of oral screen for preventing soft tissue injuries associated with use of arch bars: a prospective randomized clinical study. Oral Maxillofac Surg. 2019 Sep;23(3):291-295. doi: 10.1007/s10006-019-00780-3. Epub 2019 May 16. — View Citation

Rothe TM, Kumar P, Shah N, Shah R, Mahajan A, Kumar A. Comparative Evaluation of Efficacy of Conventional Arch Bar, Intermaxillary Fixation Screws, and Modified Arch Bar for Intermaxillary Fixation. J Maxillofac Oral Surg. 2019 Sep;18(3):412-418. doi: 10.1007/s12663-018-1110-7. Epub 2018 Apr 19. — View Citation

Saperi BS, Ramli R, Ahmed Z, Muhd Nur A, Ibrahim MI, Rashdi MF, Nordin R, Rahman NA, Yusoff A, Nazimi AJ, Abdul Rahman R, Abdul Razak N, Mohamed N. Cost analysis of facial injury treatment in two university hospitals in Malaysia: a prospective study. Clinicoecon Outcomes Res. 2017 Feb 7;9:107-113. doi: 10.2147/CEOR.S119910. eCollection 2017. — View Citation

Tracy K, Gutta R. Are embrasure wires better than arch bars for intermaxillary fixation? J Oral Maxillofac Surg. 2015 Jan;73(1):117-22. doi: 10.1016/j.joms.2014.08.020. Epub 2014 Aug 27. — View Citation

Uhthoff HK, Poitras P, Backman DS. Internal plate fixation of fractures: short history and recent developments. J Orthop Sci. 2006 Mar;11(2):118-26. doi: 10.1007/s00776-005-0984-7. — View Citation

Vadepally AK, Sinha R. Is it better to bend wires occlusally or apically during placement of arch bars for intermaxillary fixation? Br J Oral Maxillofac Surg. 2018 Jan;56(1):67-69. doi: 10.1016/j.bjoms.2017.11.006. Epub 2017 Dec 6. — View Citation

van den Bergh B, Blankestijn J, van der Ploeg T, Tuinzing DB, Forouzanfar T. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial. J Craniomaxillofac Surg. 2015 Jun;43(5):671-6. doi: 10.1016/j.jcms.2015.03.010. Epub 2015 Mar 27. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?	Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.	Assessed on the second week
Primary	Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?	Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.	Assessed on the fourth week
Secondary	Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?	Assessment of the plaque score using Turesky-Gilmore-Glickman plaque score.; There are 6 scores for this plaque index, ranging from score '0' to '5'. Score '0' means that no plaque is seen, '1' when separate flecks of plaque at the cervical margin of the tooth, '2' when a thin continuous band of plaque at the cervical margin of the tooth, '3' when a band of plaque thicker than 1mm but less than 1/3rd of the tooth surface. '4' when plaque covers at least 1/3rd but less than 2/3rd of the crown and '5' when plaque is covering 2/3rd or more of the crown of the tooth. The teeth involved in the scoring in this study are buccal surfaces of the 1st molars, premolars, canines and incisors. Since the lingual/palatal surfaces are not accessible as the teeth are wired up, it will not be assessed; Score '0' is the best while score of '5' is the worst.; This assessment is done on the fourth week after removal of the arch bar and staining of the teeth with a disclosing solution.	Assessed on the fourth week.
Secondary	Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?	The operator will assess all circumferential wires on the second week. Any loose wires will be scored as '1' and '0' if the wires are firm.; The loose wires will be retightened.	Assessed on the second week
Secondary	Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?	The operator will assess all circumferential wires on the fourth week. Any loose wires will be scored as '1' and '0' if the wires are firm.; The loose wires will be retightened.	Assessed on the fourth week

External Links

•   Dental plaque as a microbial biofilm.
•   The Acute Management of Facial Fractures