Malmö University
Malmö, Skåne County, Sweden
NCT Number: NCT07266701
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Malmö, Skåne County, Sweden
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The study is not really an intervention
It is a routine modality to take xray to se implant connection and marginal bone level.
Time frame: 2025-2028
Malmö University
Other
Precision Implant Dentistry - Bite Force Registration as Risk Assessment in Dental Implant Treatment.
Acronym: Bite force
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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