Dental ImplantBite forceNCT07266701
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.
An observational study of Dental Implant and Bruxism, run by Malmö University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Bruxism, Bite Force
- What is being tested?
- Bite force device. Innobyte Kube Innovation TM and dental radiology
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2025to 15 May 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18 years and above that understand written and spoken Swedish language.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Conditions
- Dental Implant, Bruxism, Bite Force, Dental Prosthesis Complication, Overload
- Being tested
- Bite force device. Innobyte Kube Innovation TM, dental radiology
- Keywords
- Dental implant, Bite force, dental prosthetic complications, overload
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bite force device. Innobyte Kube Innovation TMDiagnostic test
The study is not really an intervention
dental radiologyRadiation
It is a routine modality to take xray to se implant connection and marginal bone level.
| Study group | Role | What they receive |
|---|---|---|
| Adults 18 - 75 years and above who will undergo a dental implant treatment | Not described Receives: Diagnostic Test: Bite force device. Innobyte Kube Innovation TM; Radiation: dental radiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bite force in correlation to technical and biological complications in patients with dental implant treatment
Measured: 2025-2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 May 2025
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Smile Tandvård
- Responsible party
- Sponsor
- Investigators
- Tom Bergengren, Study chair, Malmö University Dental school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266701
- Sponsor's protocol ID
- 2025-00618-01
- Other IDs
- 2025
- Acronym
- Bite force
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Implant Dentistry - Bite Force Registration as Risk Assessment in Dental Implant Treatment.
- ClinicalTrials.gov ID
- NCT07266701
- Acronym / sponsor ID
- Bite force / 2025-00618-01
- Conditions
- Dental Implant, Bruxism, Bite Force, Dental Prosthesis Complication, Overload
- Keywords
- Dental implant, Bite force, dental prosthetic complications, overload
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Smile Tandvård
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2035 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults 18 - 75 years and above who will undergo a dental implant treatment | – | Diagnostic Test: Bite force device. Innobyte Kube Innovation TM, Radiation: dental radiology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults aged 18 years and above that understand written and spoken Swedish language.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bite force device. Innobyte Kube Innovation TMThe study is not really an intervention | Diagnostic test | Adults 18 - 75 years and above who will undergo a dental implant treatment |
| dental radiologyIt is a routine modality to take xray to se implant connection and marginal bone level. | Radiation | Adults 18 - 75 years and above who will undergo a dental implant treatment |
Primary outcome
Bite force in correlation to technical and biological complications in patients with dental implant treatment
Time frame: 2025-2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Bergengren study chair
Malmö University Dental school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant and Bruxism, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bite force in correlation to technical and biological complications in patients with dental implant treatment (time frame: 2025-2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.