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Oral and Maxillofacial InjuriesPINCT04059315

Epidemiology of Oral and Maxillofacial Trauma in Province 2, Nepal

An observational study of Oral and Maxillofacial Injuries, run by Tribhuvan University, Nepal at 1 site in Nepal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Trauma is one of the leading causes of death among people under 40 years of age, the causes are numerous but the majorities are involved in road traffic accidents (RTA). The oral and maxillofacial injuries are the common presentation of hospitals either as an isolated injury ( 50%) and rest 20-30% are associated with… Read more about this study

Who is it for?
Ages 1 year to 100 yearsHealthy volunteers can take part
Conditions the study is for
Oral and Maxillofacial Injuries
What is being tested?
surgical treatment of facial bone fracture
Type of treatment
Pill or oral medicine
How many people
1,030 participants
Where
1 siteNepal
Study dates
15 Aug 2019to 1 Jun 2021
How long will I take part?
2 Years
Phase
Observational
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 1 year to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The patients sustain with oral and maxillofacial injuries from the target population brought to study site hospital for advance health care. The patients have been examined, admitted and treated between study duration (10 years) will be enrolled into two-time frames separately. The patient will be identified using the ED case report file (injury report file) or operation registration database.

Who may be able to join

  • Among the patients have admitted in study sites hospital, those medical records have been maintained (not lost).
  • Patients who had seen by the investigator and had maintained a minimum of 6 weeks of follow-up for retrospective study.

Who cannot join

  • Patients who had only minor superficial soft tissue injuries which did not require admission.
  • Patients with others fracture only and are not associated with facial injuries like isolated cranial fracture or extremities fracture.
  • Patients with diagnoses different from traumatic fractures, treated by non-surgical means or other surgeons, operated for surgical sterilization purposes or for correction of previous trauma sequelae.
  • Patients whose records were lost, incomplete or illegible.

Trial locations and contacts

1 site in 1 country.

Nepal1 site
  • Dr Saroj Prasad Deo

    Birgunj, Madhesh, 43000

Other trials in Nepal

About this study

Trauma is one of the leading causes of death among people under 40 years of age, the causes are numerous but the majorities are involved in road traffic accidents (RTA). The oral and maxillofacial injuries are the common presentation of hospitals either as an isolated injury ( 50%) and rest 20-30% are associated with multiple injuries to the head, neck, chest, abdomen and extremities. These injuries may cause serious functional, psychological, physical, and cosmetic disabilities.

Maxillofacial fractures are a large public health problem with a significant negative impact on an individual's overall health and even survival. The cause, severity, and temporal distribution of maxillofacial trauma can assist in establishing clinical and research priorities for effective treatment and prevention of these injuries. Also understanding maxillofacial trauma helps to evaluate the behaviour patterns of people in different countries and to establish effective prevention and treatment strategies.

To this end, numerous studies have been carried out to explore the epidemiological features of maxillofacial fractures in different population groups. However, to best our knowledge, there is a lack of research about maxillofacial injuries for this region. Hence the main purpose of this study is to investigate the epidemiological characteristics of prevalence, aetiology, sex and age distributions, fracture site, treatment pattern, associated injuries, and complications of maxillofacial fractures treated at the National Medical College and others Hospitals of Birgunj Metropolitan city over a 10-year period from June 2011 to June 2021. A specific form (oral and maxillofacial injury proforma) will be used to collect the data from medical records of patients who had sustained oral and maxillofacial injuries and admitted as well managed at the hospitals (National Medical College and Teaching Hospital, Birganj health care, Gandak hospital, LS Neuro hospital. Birgunj). Subjects would be the patients' data's/ medical records present in hospitals, Birganj. From the patient files or medical records, following information will be gathered include demographics (e.g. age, sex), the aetiology of injury, anatomic site of the fracture, time of hospital admission and operation, presence and location of associated injuries, treatment pattern, length of in-hospital stay, and complications.

Read the detailed description

Introduction:

Trauma-related injuries claimed approximately 5 million lives in the world in 2016; is one of the leading causes of death among people in different age groups depending upon the causes of injuries (WHO, 2018a). More than quarters (29%) of these deaths were due to a road traffic accident. Low-income countries had the highest mortality rate due to a road traffic accident with 29.4 deaths per 100 000 population (WHO, 2018b). Many factors affect mortality rate and outcome after trauma (Kieser J et al 2002; Johnson J etal. 2012). Nature and severity of the injuries on the body part are the main factors for mortality of injured person. Among the mortality; fatality rate is 50 % within a few minutes of trauma due to damage to the brain or spinal cord or heart or major vessel or organ. Another factor affecting mortality is the standard of surgical care in the hospital; 30% die in the hospital a few hour injuries due to hypoxia and haemorrhage (hypovolemic shock). Late mortality is seen within a day to a week in hospital (20%) due to sepsis and multiorgan failure (Kovacs G, Sowers N., 2018; Prathigudupu RS et al.,2018; ).

Oral and Maxillofacial trauma is a common presentation in Emergency departments (ED) of the hospitals (Kieser J et al 2002; Wong NH etal 2012; Calderoni DR etal 2011; Katarzyna B etal 2010). Age of the patient, concomitant head injuries, airway obstruction, a pattern of facial bone fracture and increased bleeding are some of the variables of increasing death rates after maxillofacial trauma (Katarzyna B etal 2010; Kovacs G, Sowers N., 2018). Multiple body part injuries are often associated with oral and maxillofacial injuries in severely injured trauma patients(Kieser J et al, 2002; Wong NH etal, 2012; Calderoni DR etal, 2011; Katarzyna B etal. 2010; Prathigudupu RS et al, 2018; Davies MJ et al 2012). The diagnosis, as well as management of complicated facial fractures, is challenging even to the most experienced oral and maxillofacial surgeons, while the presence of coexistent injuries and the complexity of these injuries make it more difficult to consolidate experience and develop realistic treatment protocols. Furthermore, the lack of sufficient specialist facial trauma units results in unacceptable delays from referral to operation, complicating the management and compromising the outcome. Coordination of trauma teams, emergency room physicians, and surgical teams such as neurosurgeons, orthopaedic is vital for the early stabilization and treatment of patients with facial bone fracture (Wong NH et al, 2012; Davies MJ et al, 2012; Follmar KE et al,2007; Van Hout WM et al ,2013, Kostakis G et al, 2012). These injuries may cause serious functional, psychological, physical, and cosmetic disabilities (Kim JW et al 2015; Zachariades N et al 1993) .

The epidemiology of oral and maxillofacial trauma varies from one geographical region to another and even within the same region depending on the many risk factors such as demographic, socioeconomic, cultural, personal behaviour, mental status and environmental factors ( Mathog RH et al, 2000; Fasola AO et al, 2003;Branas CC et al, 2004; Li Z and Li ZB, 2008 ). The common causes worldwide are road traffic accidents (20-83%) (Lee JH et al, 2010; Karagozoglu KH et al, 2012; Walker TW et al 2013; Forouzanfar T et al. 2013; Mijiti A et al, 2014;Jung CP et al, 2016 ); assault( 18- 79%) (Ugboko VI et al 1998; Laskin DM and Best AM, 2000; Olasoji HO et al, 2002; Adebayo ET et al ,2003; Al Ahmed HE et al, 2004; Brasileiro BF et al, 2006; Lee K, 2009a; Lee KH, 2009b; Mijiti A et al, 2014), falls( 10-17% ) (Shankar AN et al, 2012; Van den Bergh B et al 2012; Salentijn EG et al, 2013; Mijiti A et al, 2014), sport injuries (3-7% ) (Bamjee Y et al, 1996; Qudah MA et al, 2002; Al-Khateeb T et al 2007; Bakardjiev A et al, 2007; de Matos FP et al 2010) , hit by moving object ( 5- 15%) (Sakr K, Farag IA et al 2006; Subhashraj K et al, 2007; Thorén H et al, 2010; Chrcanovic BR et al, 2012), bicycle accident ( 2-28% ) (Gomes PP et al, 2006; Kotecha S et al, 2008; Lee JH et al, 2010; Forouzanfar T et al, 2013) , work-related accident (1.7-7% ) (Gassner R et al 2003; Qing-Bin Z et al, 2013) and miscellaneous ( 1.3 %) include pathological fractures, blast injuries, animal attack accident, tooth extraction, and unknown etiology.

Facial bone fractures are a large public health problem with a significant negative impact on an individual's overall health and even survival (Kim JW et al , 2015; Kovacs G, Sowers N, 2018; Prathigudupu RS et al, 2018) . Addressing socio-cultural issues, reviewing and improving road safety legislation, enforcing infrastructure and vehicle standards, and improving post-crash care remain critical to preventing avoidable deaths and disabilities caused by road crashes - which continue to be a major public health challenge ( Mathog RH et al, 2010; Kim JW et al, 2015). Despite the legislative changes and preventative measures involving seatbelt and airbag use, as well as the reduction of drinking and driving, road traffic accidents are still the major cause of facial fractures in many developing countries.

This part of the country ( Provinces 2), is the second most populous province of the country Nepal, located in the central south of the country spans over 9,661 km2 (3,730 sq mi), with a 5,404,145 population of (according to the CBS 2015 year census). Majority of people are poor (48%), illiterates 32% overall and major source of income is agriculture and foreign worker (Wikipedia, 2019). It borders with Bihar states of India. Among the many factors social and cultural similarity, the people of Bihar is presented in this regional hospital for treatment. The road, a major means of transportation here but the condition of the road is very bad.

The main purpose of this study is to investigate the epidemiological characteristics of prevalence, aetiology, sex and age distributions, fracture site, treatment pattern, associated injuries, and complications of maxillofacial fractures treated at the National Medical College and others Hospitals of Birgunj Metropolitan city over a 10-year period from June 2011 to June

Statement of the Problem and Rationale / Justification:

A clearer understanding of the demographic patterns of maxillofacial injuries will assist health care providers as they plan and manage the treatment of traumatic maxillofacial injuries (Al Ahmed et al., 2004; Lee K, 2009; Mijiti A et al., 2014). Such epidemiological information can also be used to guide the future funding of public health programs geared towards prevention.

Understanding maxillofacial trauma helps to evaluate the behaviour patterns of people in different countries and to establish effective prevention and treatment strategies (Maliska et al., 2009; Katarzyna B, Piotr A 2010).

Understanding the cause, severity, and temporal distribution of maxillofacial trauma can assist in establishing clinical and research priorities for effective treatment and prevention of these injuries (Gassner et al., 2003; Qing-Bin Z et al., 2013).

To this end, numerous studies have been carried out to explore the epidemiological features of maxillofacial fractures in different population groups (Ugboko VI et al., 1998; Kieser J et al., 2002; Olasoji HO et al., 2002; Qudah MA et al., 2002; Fasola AO et al., 2003; Al Ahmed HE et al., 2004; Ansari MH., 2004; Gomes PP et al., 2006; Sakr K et al., 2006; Al-Khateeb T et al., 2017; Bakardjiev A et al., 2007; Lee JH et al., 2010; Walker TW et al., 2012; Forouzanfar T et al., 2013; Qing-Bin Z et al., 2013; Van Hout WM et al., 2013; Mijiti A et al., 2014; Jung CP et al., 2016; Nogami S et al., 2019). However, to best our knowledge, there is a lack of reports detailing the causes, incidence, and treatment pattern of maxillofacial injuries, and no study has been published about oral and maxillofacial injuries analysis for this region.

Being tested
surgical treatment of facial bone fracture
Keywords
motor vehicle accident, epidemiology, facial fracture
Medical subject headings
Maxillofacial Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgical treatment of facial bone fractureOther

    oral and maxillofacial injury patients admitted in our hospital. patients are getting treatment of soft and bone frature as follow soft tissue repaire, IMF, ORIF, consrvative.

Study groups in NCT04059315
Study groupRoleWhat they receive
Retrospective cross sectional studyThis is an Epidemiological observational analytic study where the subjects sustained with oral and maxillofacial trauma will be divided into the two-time-frame; 1st, retrospective study between 1 June 2011 to 31 May 2019
Receives: Other: surgical treatment of facial bone fracture
Prospective cohort study2nd prospective study on 1 June 2019 to 1 June 2021.
Receives: Other: surgical treatment of facial bone fracture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of causes and risk factors of oral and maxillofacial injuries

    This is a pro-retrospective observational study of oral and maxillofacial injuries, is a large public health problem with a significant negative impact on an individual's overall health and even survival. A gender, age, marital status, ethnicity, address, education, occupation, socioeconomically status are variables of trauma. These parameters will be documented in a special form called oral and maxillofacial proforma which is standard, reliable and valid format exceeds the current minimum requirements for clinical governance, addresses and improves the amount of data that is recorded and disseminated during handover.

    Measured: 2019-2021

Secondary outcomes (2)
  1. The role of the health care provider in the management of oral and maxillofacial injuries.

    Multidisciplinary approaches are required to manage oral and maxillofacial injuries because mainly associated with other injuries. The primary survey is very important to preserve the life of the patients ie ABCDE. Definite management is performed only after proper diagnosis on the basis of clinical or radiological examination, or both. A facial fracture is documented as a standard classification of the zygoma, the accompanying ipsilateral orbital fracture. In the case of a Le Fort II or III fracture, the accompanying nasal and orbital fractures are documented separately.

    Information about the method of treatment will be gathered from the operating notes and will be categorised as open reduction and internal fixation, intermaxillary fixation, reposition without fixation, or orbital floor repair. Other injuries are categorised as neurotrauma, spinal trauma, orthopaedic trauma, general surgical trauma, and other trauma.

    Measured: 2019-2021

  2. Early and late morbidity and mortality assessment in oral and maxillofacial trauma .

    Early and late complication associated with oral and maxillofacial injury are seen in many circumstances in a period of time. Treatment-Related Adverse Events as Assessed by in trauma. In this study, participants would be followed up 2nd, 6th, 12th, 24th, 48th, 72 and 96th week postoperative. The proforma is used for documentation of complication.

    Measured: 2019-2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2019
  2. Study start15 Aug 2019
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,030 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04059315
Sponsor's protocol ID
397-2019
Acronym
PI
Status last verified
Aug 2019
First submitted
31 Jul 2019
Last updated
4 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data collection to proforma that can be shared with the researcher in the world.

Publications

  • Adebayo ET, Ajike OS, Adekeye EO. Analysis of the pattern of maxillofacial fractures in Kaduna, Nigeria. Br J Oral Maxillofac Surg. 2003 Dec;41(6):396-400. doi: 10.1016/s0266-4356(03)00165-7.

    PubMed 14614869
  • Al Ahmed HE, Jaber MA, Abu Fanas SH, Karas M. The pattern of maxillofacial fractures in Sharjah, United Arab Emirates: a review of 230 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Aug;98(2):166-70. doi: 10.1016/j.tripleo.2004.01.020.

    PubMed 15316543
  • Al-Khateeb T, Abdullah FM. Craniomaxillofacial injuries in the United Arab Emirates: a retrospective study. J Oral Maxillofac Surg. 2007 Jun;65(6):1094-101. doi: 10.1016/j.joms.2006.09.013.

    PubMed 17517291
  • Branas CC, Nance ML, Elliott MR, Richmond TS, Schwab CW. Urban-rural shifts in intentional firearm death: different causes, same results. Am J Public Health. 2004 Oct;94(10):1750-5. doi: 10.2105/ajph.94.10.1750.

    PubMed 15451745
  • Bamjee Y, Lownie JF, Cleaton-Jones PE, Lownie MA. Maxillofacial injuries in a group of South Africans under 18 years of age. Br J Oral Maxillofac Surg. 1996 Aug;34(4):298-302. doi: 10.1016/s0266-4356(96)90006-6.

    PubMed 8866064
  • Brasileiro BF, Passeri LA. Epidemiological analysis of maxillofacial fractures in Brazil: a 5-year prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Jul;102(1):28-34. doi: 10.1016/j.tripleo.2005.07.023. Epub 2006 Mar 22.

    PubMed 16831669
  • Boffano P, Roccia F, Gallesio C, Karagozoglu KH, Forouzanfar T. Bicycle-related maxillofacial injuries: a double-center study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Sep;116(3):275-80. doi: 10.1016/j.oooo.2013.03.004. Epub 2013 May 7.

    PubMed 23663988
  • Boffano P, Roccia F, Zavattero E, Dediol E, Uglesic V, Kovacic Z, Vesnaver A, Konstantinovic VS, Petrovic M, Stephens J, Kanzaria A, Bhatti N, Holmes S, Pechalova PF, Bakardjiev AG, Malanchuk VA, Kopchak AV, Galteland P, Mjoen E, Skjelbred P, Koudougou C, Mouallem G, Corre P, Loes S, Lekven N, Laverick S, Gordon P, Tamme T, Akermann S, Karagozoglu KH, Kommers SC, Forouzanfar T. European Maxillofacial Trauma (EURMAT) project: a multicentre and prospective study. J Craniomaxillofac Surg. 2015 Jan;43(1):62-70. doi: 10.1016/j.jcms.2014.10.011. Epub 2014 Oct 22.

    PubMed 25457465
  • Calderoni DR, Guidi Mde C, Kharmandayan P, Nunes PH. Seven-year institutional experience in the surgical treatment of orbito-zygomatic fractures. J Craniomaxillofac Surg. 2011 Dec;39(8):593-9. doi: 10.1016/j.jcms.2010.11.018. Epub 2010 Dec 30.

    PubMed 21195624
  • Chrcanovic BR, Abreu MH, Freire-Maia B, Souza LN. 1,454 mandibular fractures: a 3-year study in a hospital in Belo Horizonte, Brazil. J Craniomaxillofac Surg. 2012 Feb;40(2):116-23. doi: 10.1016/j.jcms.2011.03.012. Epub 2011 Mar 31.

    PubMed 21458284
  • de Matos FP, Arnez MF, Sverzut CE, Trivellato AE. A retrospective study of mandibular fracture in a 40-month period. Int J Oral Maxillofac Surg. 2010 Jan;39(1):10-5. doi: 10.1016/j.ijom.2009.10.005. Epub 2009 Nov 14.

    PubMed 19914802
  • Davies MJ, Wells C, Squires PA, Hodgetts TJ, Lecky FE. Civilian firearm injury and death in England and Wales. Emerg Med J. 2012 Jan;29(1):10-4. doi: 10.1136/emj.2009.085837. Epub 2011 Nov 4.

    PubMed 22058090
  • Fasola AO, Nyako EA, Obiechina AE, Arotiba JT. Trends in the characteristics of maxillofacial fractures in Nigeria. J Oral Maxillofac Surg. 2003 Oct;61(10):1140-3. doi: 10.1016/s0278-2391(03)00671-2.

    PubMed 14586847
  • Follmar KE, Debruijn M, Baccarani A, Bruno AD, Mukundan S, Erdmann D, Marcus JR. Concomitant injuries in patients with panfacial fractures. J Trauma. 2007 Oct;63(4):831-5. doi: 10.1097/TA.0b013e3181492f41.

    PubMed 18090013
  • Forouzanfar T, Salentijn E, Peng G, van den Bergh B. A 10-year analysis of the "Amsterdam" protocol in the treatment of zygomatic complex fractures. J Craniomaxillofac Surg. 2013 Oct;41(7):616-22. doi: 10.1016/j.jcms.2012.12.004. Epub 2013 Jan 30.

    PubMed 23375533

Questions about this trial

What is this clinical trial studying?

An observational study of Oral and Maxillofacial Injuries, run by Tribhuvan University, Nepal at 1 site in Nepal.

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 2 inclusion and 4 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 4 Sep 2019. 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 Nepal. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of causes and risk factors of oral and maxillofacial injuries (time frame: 2019-2021). 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 NCT04059315, which also lists 49 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 4 Sep 2019.

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