Patients 60 Years and Older Suffering From Mandibular Fractures Registry
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|ClinicalTrials.gov Identifier: NCT03849898|
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : August 13, 2020
|Condition or disease||Intervention/treatment|
|Mandibular Fractures||Procedure: Surgery Other: Non-Surgical fracture 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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|
Elderly patients of > 60 years who present a mandibular fracture
Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice
Surgical fracture treatment
Other Name: Operative
Other: Non-Surgical fracture treatment
Non-Surgical fracture treatment
- 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.
- 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
- 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
- Not assessable (in case of edentulous patients or who use prosthesis)
- 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.
- Mandibular dysfunction (Helkimo index) [ Time Frame: 2 weeks / 6 weeks / 3 months / 6 months ]
Evaluation by means Helkimo Index:
- Impaired range of movement (0 normal, 1 slight, 5 severely)
- 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)
- Muscle pain (0 no tenderness, 1 tenderness to palpation in 1-3 palpation sites, 5 tenderness in 4 or more palpation sites)
- Temporomandibular joint pain (0 no tenderness, 1 tenderness to palpation laterally, 5 tenderness to palpation posteriority)
- 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
- 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
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
|Contact: Joffrey Baczkowski||+41 44 200 24 email@example.com|
|Contact: Victor Diaz, PhD||+41 81 414 25 firstname.lastname@example.org|
|Principal Investigator:||Risto Kontio, Prof.||Department of Oral and Maxillofacial Surgery, Helsinki University Hospital|