Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patients 60 Years and Older Suffering From Mandibular Fractures Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849898
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:
Approximately 200 of patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

Condition or disease Intervention/treatment
Mandibular Fractures Procedure: Surgery Other: Non-Surgical fracture treatment

Detailed Description:

Patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated (surgical or non-surgical) and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

Data collection will include patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications). Radiographs and/or other images (e.g. CT scan) taken as per standard of care will be collected within the registry.

Primary objectives are to obtain epidemiological data and describe the most common mandibular fracture patterns in older patients, to explore the relationship(s) between the treatment of mandibular fractures and its outcome in older patients, to identify risk factors and initiating factors of elderly related to mandible fracture events and to describe concomitant fractures associated with mandibular fractures in older patients.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Mandibular Fracture

Elderly patients of > 60 years who present a mandibular fracture

Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice

Procedure: Surgery
Surgical fracture treatment
Other Name: Operative

Other: Non-Surgical fracture treatment
Non-Surgical fracture treatment




Primary Outcome Measures :
  1. Patient-reported outcome [ Time Frame: Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months ]

    Change in Geriatric/general Oral Self Assessment Index (GOHAI) over the follow up period:

    Self-reported measurement to describe three hypothetical dimensions 1) physical function, 2) psychosocial function and 3) pain and/or discomfort. It consisted of 12 items evaluated using a 5-point Likert from "never" to "always" in which higher scores indicated better outcomes.



Other Outcome Measures:
  1. Occlusal Status [ Time Frame: 2 weeks / 6 weeks / 3 months / 6 months ]

    Occlusion will be assessed without the use of dentures and classified follows:

    • Normal for the patient
    • Abnormal for the patient (multiple options possible)

      • Anterior open bite
      • Crossbite
      • Lateral open bite in the premolar area
      • Lateral open bite in the molar area
      • Deep bite: missing molar and/or pre-molar to support occlusion
      • Other
    • Not assessable (in case of edentulous patients or who use prosthesis)

  2. Degree of malocclusion (if present) [ Time Frame: 2 weeks / 6 weeks / 3 months / 6 months ]
    The thin-paper bite test will be used to evaluate the status of the occlusion. This test will be performed only if malocclusion is detected. Patients will be asked to close the mouth and bring teeth together while biting into a thin paper (<1mm). Deviations between opposite teeth greater than 1mm will be assessed as major, while deviations <1mm will be assessed as minor.

  3. Mandibular dysfunction (Helkimo index) [ Time Frame: 2 weeks / 6 weeks / 3 months / 6 months ]

    Evaluation by means Helkimo Index:

    1. Impaired range of movement (0 normal, 1 slight, 5 severely)
    2. Impaired temporomandibular joint function (0 smooth movement without joint sounds, 1 joint sounds in one or both joints, 5 locking and/or luxation of joint)
    3. Muscle pain (0 no tenderness, 1 tenderness to palpation in 1-3 palpation sites, 5 tenderness in 4 or more palpation sites)
    4. Temporomandibular joint pain (0 no tenderness, 1 tenderness to palpation laterally, 5 tenderness to palpation posteriority)
    5. Pain on movement (0 no pain, 1 pain one movement, 5 pain on two or more movements)

    Patients will be classified according to their score as follow:

    • 0 points, clinically symptom free
    • 1 - 4 points: mild dysfunction
    • 5 - 9 points: moderate dysfunction
    • 10 - 13 points: severe dysfunction
    • 15 - 17 points: severe dysfunction
    • 20 - 25 points: severe dysfunction

  4. Mandibular Movements (mobility index) [ Time Frame: 2 weeks / 6 weeks / 3 months / 6 months ]
    • Interincisal opening/maximal opening is defined as distance in millimeters between the edges of the incisors of the mandibular and the maxillary bone.
    • Lateral movements: With the mandible slightly open, it is defined as the distance in millimeters from the labioincisal embrasure between the central incisors to the labioincisal embrasure of the mandibular incisors
    • Protrusive movement: With the mandible slightly open, it is defined as the distance in millimeters between the incisal edges of the maxillary central incisor to the mandibular central incisor.

    Depending on the score, the mobility index will be calculated as follow:

    • 0 points: normal mandibular mobility
    • 1 - 4 points: slightly impaired mobility
    • 5 - 20 points: severely impaired mobility



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)
Criteria

Inclusion Criteria:

  • Age > 60 years at the time of the injury
  • Diagnosis of any kind of mandibular fracture
  • Informed consent obtained, i.e.:

    • Ability to understand the content of the patient information/ informed consent form (ICF)
    • Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
    • Signed and dated EC/IRB approved written informed consent OR For patients who are not able to provide independent written informed consent: Written consent provided according to defined and IRB/EC approved procedures

Exclusion Criteria:

  • Patients with previous history of mandibular fractures or mandibular defects treated surgically
  • Participation in any other medical device or medicinal product study within the previous months that could influence bone healing and the results of the present study in the opinion of the treating physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849898


Contacts
Layout table for location contacts
Contact: Joffrey Baczkowski +41 44 200 24 31 joffrey.baczkowski@aofoundation.org
Contact: Victor Diaz, PhD +41 81 414 25 07 victor.diaz@aofoundation.org

  Show 23 Study Locations
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Layout table for investigator information
Principal Investigator: Risto Kontio, Prof. Department of Oral and Maxillofacial Surgery, Helsinki University Hospital

Additional Information:

Layout table for additonal information
Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT03849898     History of Changes
Other Study ID Numbers: MFx 60+_RP_v.1.0
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AO Clinical Investigation and Documentation:
Fracture fixation
Surgical treatment
Non-Surgical treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Mandibular Fractures
Fractures, Bone
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures