Maxillofacial InjuriesNCT05801328
Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar
A study testing Ending of the wires on Erich arch bar in the occlusal direction in people with Maxillofacial Injuries, run by Universiti Sains Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Maxillofacial Injuries
- What is being tested?
- Ending of the wires on Erich arch bar in the occlusal direction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- All pathologic fractures due to cysts, tumors, and cancers
- Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
NG Kar Tsyeng, BDS, 0165216351, kartsyeng86@hotmail.com
NG Kar Tsyeng, BDS
About this study
Official title: Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial
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)
- Conditions
- Maxillofacial Injuries
- Being tested
- Ending of the wires on Erich arch bar in the occlusal direction
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ending of the wires on Erich arch bar in the occlusal directionDevice
The wires of the Erich arch bar will be placed on the occlusal direction
| Study group | Role | What they receive |
|---|---|---|
| Occlusal ending of wires | Experimental | The wires will be bent occlusally for the interventional side Receives: Device: Ending of the wires on Erich arch bar in the occlusal direction |
| Apical ending of wires | No intervention | The wires will be bent apically for the control side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Assessed on the second week
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'.
Measured: Assessed on the fourth week
Secondary outcomes (3)
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.
Measured: Assessed on the fourth week.
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.
Measured: Assessed on the second week
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.
Measured: Assessed on the fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this is a split mouth study. Participants teeth will be divided into left or right side and randomised into either control or intervention side.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ng Kar Tsyeng, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801328
- Sponsor's protocol ID
- USM/JEPeM/22110704
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16270942Qureshi 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.
PubMed 27563602Bali 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.
PubMed 20488595de 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.
PubMed 23245627Farber 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.
PubMed 26207551Fasoulas 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.
PubMed 31334380Fernandes 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.
PubMed 32798159Garra 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.
PubMed 20003121Gilardino 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.
PubMed 22110797Haggard 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.
PubMed 25284337Hamid 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.
PubMed 35265493Jain 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.
PubMed 34315565Kirk 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.
PubMed 26546844Koshy 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.
PubMed 22550460Loe 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.
PubMed 10967765
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05801328
- Acronym / sponsor ID
- USM/JEPeM/22110704
- Conditions
- Maxillofacial Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- this is a split mouth study. Participants teeth will be divided into left or right side and randomised into either control or intervention side.
| Arm | Type | Receives |
|---|---|---|
| Occlusal ending of wires | Experimental | Device: Ending of the wires on Erich arch bar in the occlusal directionThe wires will be bent occlusally for the interventional side |
| Apical ending of wires | No intervention | –The wires will be bent apically for the control side. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- All pathologic fractures due to cysts, tumors, and cancers
- Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ending of the wires on Erich arch bar in the occlusal directionThe wires of the Erich arch bar will be placed on the occlusal direction | Device | Occlusal ending of wires |
Primary outcome
Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
Time frame: Assessed on the second week
Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.
Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
Time frame: Assessed on the fourth week
Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.
3 secondary outcomes
Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?
Time frame: Assessed on the fourth week.
Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?
Time frame: Assessed on the second week
Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?
Time frame: Assessed on the fourth week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 16270942Adeyemo 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.
- Background: PubMed 27563602Qureshi 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.
- Background: PubMed 20488595Bali 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.
- Background: PubMed 23245627de 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.
- Background: PubMed 26207551Farber 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.
- Background: PubMed 31334380Fasoulas 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.
- Background: PubMed 32798159Fernandes 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.
- Background: PubMed 20003121Garra 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.
- Background: PubMed 22110797Gilardino 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.
- Background: PubMed 25284337Haggard 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.
- Background: PubMed 35265493Hamid 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.
- Background: PubMed 34315565Jain 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.
- Individual participant dataSharing planned: No
Related trials for Maxillofacial Injuries
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ending of the wires on Erich arch bar in the occlusal direction in people with Maxillofacial Injuries, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NG Kar Tsyeng, BDS (0165216351, kartsyeng86@Hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Are there any differences between occlusally and apically bent groups in terms of mucosal trauma? (time frame: Assessed on the second week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801328, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.