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)

November 24, 2025 updated by: Malmö University

Precision Implant Dentistry - Bite Force Registration as Risk Assessment in Dental Implant Treatment.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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:

  • Screening - 3Q/TMD
  • Stress - PSS-10
  • Jaw function - JFLS-8
  • Use of splint
  • Brux-Screen

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne County
      • Malmo, Skåne County, Sweden
        • Malmö University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adults aged 18 years and above that understand written and spoken Swedish language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults 18 - 75 years and above who will undergo a dental implant treatment
Diagnostic test: Bite force device. Innobyte Kube Innovation TM
The study is not really an intervention
Radiation: dental radiology
It is a routine modality to take xray to se implant connection and marginal bone level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bite force in correlation to technical and biological complications in patients with dental implant treatment
Time Frame: 2025-2028
2025-2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malmö University

Collaborators

Smile Tandvård

Investigators

  • Study Chair: Tom Bergengren, Malmö University Dental school

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2035

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-00618-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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