The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
NCT ID: NCT07266701
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
85 participants
OBSERVATIONAL
2025-05-15
2035-05-15
Brief Summary
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The main questions it aims to answer are:
* Can we risk-assess patients regarding overload based on bite force measurement before dental implant treatment?
* Can we profile patients based on bite force to tailor precise dental implant treatment for individual patients?
* Will this profiling lead to improved prognosis by reduced number of technical and/or biological complications?
Participants with dental implant prostheses get their bite force measured and followed every year up to 10 years to see complications.
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Detailed Description
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Specific research questions - Study 2: Prospective clinical trial analyzing bite force and technical complications in patients receiving dental implant treatment.,
* Does bite force differ between patients who do/do not experience complications?
* Does high bite force measurement correlate with the number of technical complications in patients receiving dental implant treatment in a normal population?
* Can we identify at what force risk for fractures becomes significant?
* Does high bite force correlate with peri-implant bone loss?
Patients who accept participation will attend an examination where bilateral bite force will be recorded usin Innobyte, a highly sensitive, calibrated bilateral transducer (InnobyteTM, Kube Innovation) capable of measuring wide ranges of bite forces with good accuracy using digital display not visible to the participant.
Experimental procedure Participants are instructed to abstain from using analgesics or alcohol for 24 hours before the test as well as eating, chewing gum or tobacco products 1 hour before the session.
Participants will be seated upright in a dental chair. Participants will perform one initial maximum bite force registration to familiarize themselves with the equipment. After this, the participants will be asked to bite on the padded force transducer as hard as possible (the time needed to achieve maximum bite force is determined by the subject but typically 2 to 5 seconds). Three such measurements will be recorded with a 30-second rest in between, and the average will be calculated and registered.
All tests are carried out in one experimental session that will take approximately 10 minutes.
Baseline radiographs as well as radiographs taken at follow-up visits will be reviewed for signs of bone loss. Registrations of bleeding on probing and pocket depth will be done to determine presence of peri-implant mucositis or peri-implantitis.
Any identified technical or biological complications and/or signs of wear (measured according to TWES 3.0) will be registered together with data regarding patient age and gender, type of implant restoration, restorative material, opposing dentition and time after delivery of the prosthetic construction.
Participants will be asked to answer a questionnaire evaluating orofacial pain and jaw function and factors that may affect this. The questionnaire includes initial screening questions as well as validated instruments:
* Screening - 3Q/TMD
* Stress - PSS-10
* Jaw function - JFLS-8
* Use of splint
* Brux-Screen
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults 18 - 75 years and above who will undergo a dental implant treatment
Bite force device. Innobyte Kube Innovation TM
The study is not really an intervention
dental radiology
It is a routine modality to take xray to se implant connection and marginal bone level.
Interventions
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Bite force device. Innobyte Kube Innovation TM
The study is not really an intervention
dental radiology
It is a routine modality to take xray to se implant connection and marginal bone level.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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Smile Tandvård
UNKNOWN
Malmö University
OTHER
Responsible Party
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Principal Investigators
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Tom Bergengren
Role: STUDY_CHAIR
Malmö University Dental school
Locations
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Malmö University
Malmo, Skåne County, Sweden
Countries
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Other Identifiers
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2025-00618-01
Identifier Type: -
Identifier Source: org_study_id
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