An observational study in Mandibular Fractures, sponsored by AO Clinical Investigation and Publishing Documentation. Terminated at 24 sites in 15 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by AO Clinical Investigation and Publishing Documentation · Observational
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.
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.
84 studies on the registry are indexed under Mandibular Fractures; 20 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 19 observational studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 50 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Informed consent obtained, i.e.:
Exclusion Criteria:
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 · Other: Non-Surgical fracture treatment
Surgical fracture treatment
Also known as: Operative
Non-Surgical fracture treatment
Patient-reported outcome
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.
Time frame: Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months
Occlusal Status
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)
Time frame: 2 weeks / 6 weeks / 3 months / 6 months
Degree of malocclusion (if present)
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.
Time frame: 2 weeks / 6 weeks / 3 months / 6 months
Mandibular dysfunction (Helkimo index)
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
Time frame: 2 weeks / 6 weeks / 3 months / 6 months
Mandibular Movements (mobility index)
* 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
Time frame: 2 weeks / 6 weeks / 3 months / 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AO Clinical Investigation and Publishing Documentation