An observational study in Dental Implant, Bruxism and Bite Force, sponsored by Malmö University. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Malmö University · Observational
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:
Participants with dental implant prostheses get their bite force measured and followed every year up to 10 years to see complications.
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.,
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:
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's planned enrollment of 85 is close to the median of 89 across 55 observational studies indexed under Bruxism.
Browse Bruxism studies →Malmö University is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from patients who are planned to undergo, or who have undergone, dental implant treatment at any of the general dentist clinics within the Smile Tandvård AB group and other private practices and university setting at Malmö University, Universitetstandvården.
Inclusion Criteria:
Diagnostic Test: Bite force device. Innobyte Kube Innovation TM · Radiation: dental radiology
The study is not really an intervention
It is a routine modality to take xray to se implant connection and marginal bone level.
Bite force in correlation to technical and biological complications in patients with dental implant treatment
Time frame: 2025-2028
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Malmö University