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. (Bite force)

Malmö University

Status

Invitation-only

Conditions

Bruxism

Overload

Bite Force

Dental Prosthesis Complication

Dental Implant

Treatments

Diagnostic Test: Bite force device. Innobyte Kube Innovation TM

Radiation: dental radiology

Study type

Observational

Funder types

Other

Identifiers

NCT07266701

2025-00618-01

Details and patient eligibility

About

The general aim of this clinical trial is to implement clinical assessment of overload by bite force registration to enable future simple but precise risk assessment to provide individualized treatment plans.

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.

Full description

The general aims will be tried to answer with two studies. One prospect and one retrospective.

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: