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.

NCT07266701 | Enrolling By Invitation DMC

• 1 other identifier: 2025-00618-01
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Implant; Bruxism; Bite Force; Dental Prosthesis Complication; Overload

Keywords

Dental implant; Bite force; dental prosthetic complications; overload

Outcome Measures

Primary Outcomes (1)

• Bite force in correlation to technical and biological complications in patients with dental implant treatment

  2025-2028

Study Arms (1)

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

Interventions

dental radiology RADIATION

It is a routine modality to take xray to se implant connection and marginal bone level.

Adults 18 - 75 years and above who will undergo a dental implant treatment

Bite force device. Innobyte Kube Innovation TM DIAGNOSTIC_TEST

The study is not really an intervention

Adults 18 - 75 years and above who will undergo a dental implant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Smile Tandvård: collaborator
• Malmö University: lead

Study Sites (1)

Malmö University

Malmo, Skåne County, Sweden

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Officials

• Tom Bergengren

  Malmö University Dental school

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2035
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)