Occlusal AnalysisNCT06862973
Digital Analysis of Occlusal Force Distribution in Single-Tooth Implant Restorations
An observational study of Occlusal Analysis, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
This study will explore the impact of single tooth implant restorations upon occlusal force distribution and the accuracy of several digital analysis methods. The biomechanical behavior of implant-supported prostheses differs from that of natural teeth, and the distribution and modulation of occlusal forces are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occlusal Analysis
- What is being tested?
- Digital Occlusal Analysis Using Medit i700 and OccluSense in Single-Tooth Implant Restorations
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: he study population consists of adult patients requiring single posterior implant-supported restorations at Necmettin Erbakan University Faculty of Dentistry. Participants are selected based on specific inclusion criteria, including good periodontal health, a single missing tooth in the posterior region, and stable occlusion (Class I bite). Patients with a history of temporomandibular joint disorders, acute pain, occlusal dysfunction, restricted mouth opening, or prior orthodontic or surgical treatments affecting occlusion are excluded. The study aims to assess occlusal force distribution changes in a clinically relevant population undergoing implant rehabilitation, providing insights into post-restorative occlusal adjustments.
Who may be able to join
- Individuals aged 18 and over
- Patients with good periodontal health
- Patients with a Class I bite
- Patients with a single tooth deficiency in the posterior region planned for rehabilitation with an implant-supported single crown restoration
Who cannot join
- History of temporomandibular joint disease
- Acute pain or signs of occlusal dysfunction
- Restricted mouth opening
- Absence of a tooth distal to the planned restoration
- Occlusion instability due to prior orthodontic or surgical treatments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Necmettin Erbakan University
Konya, Meram, 42090
About this study
Official title: Comparison of Occlusal Force Distribution and Digital Occlusal Analysis Methods of Single Posterior Implant Restorations and Digital Occlusal Analysis Methods
This study will explore the impact of single tooth implant restorations upon occlusal force distribution and the accuracy of several digital analysis methods. The biomechanical behavior of implant-supported prostheses differs from that of natural teeth, and the distribution and modulation of occlusal forces are unpredictable.
The research used the Medit i700 intraoral scanner and the OccluSense system to take pre- and post-implant measurements. The research aims to determine: How are the techniques different in the registration of occlusal contacts and force magnitude? and How does occlusal balance shift following the placement of an implant? The research findings can be used to provide clinical recommendations to optimize occlusal balancing during implant prosthetics.
- Conditions
- Occlusal Analysis
- Being tested
- Digital Occlusal Analysis Using Medit i700 and OccluSense in Single-Tooth Implant Restorations
- Keywords
- Occlusion, Dental Implant, Occlusal Analysis, OccluSense, Medit i700
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Occlusal Analysis Using Medit i700 and OccluSense in Single-Tooth Implant RestorationsDiagnostic test
This study differs from other research through the comparison of two advanced digital occlusal analysis methods-OccluSense system and MEDIT i700 intraoral scanner-to measure occlusal force distribution both before and after the insertion of single-tooth implant restorations in the posterior segment. Unlike research based upon the use of articulation paper, this study employs pressure-sensitive sensor technology (OccluSense) and scanner-based occlusion analysis (MEDIT i700) to quantitatively measure occlusal contacts and force intensity using CloudCompare and ImageJ. With the analysis of the variations that take place within the pre-and-post implant occlusion, the study provides an understanding of occlusal adaptation and how to optimize occlusal adjustments to prevent implant overload and complications, differing from the research that has previously lacked both digital force mapping and longitudinal occlusal analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Occlusal Force Distribution from Pre-Implant to Post-Implant Restoration as Measured by Medit i700 and OccluSense
Occlusal force distribution was measured before and after single-tooth implant restoration using two digital occlusal analysis methods: Medit i700 intraoral scanner and OccluSense pressure sensor system. Measurements were taken under standardized conditions, ensuring maximum intercuspation position. Medit i700 provided contact area data through intraoral scans, analyzed with CloudCompare software, while OccluSense recorded occlusal force intensity and distribution, analyzed with ImageJ software. The percentage change in occlusal contact areas and force distribution was calculated between the pre- and post-implant conditions. A statistically significant change (p < 0.05) indicates an alteration in occlusal balance following the restoration.
Measured: From pre-implant assessment to 2 week after final implant restoration placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start30 Sep 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occlusal AnalysisStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Gözen, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862973
- Sponsor's protocol ID
- 20754
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes, all IPD that underlie results in a publication
Publications
Gozen M, Guntekin N. Comparison of occlusal force distribution and digital occlusal analysis methods of single posterior implant restorations: an in vivo study. BMC Oral Health. 2025 May 26;25(1):795. doi: 10.1186/s12903-025-06205-w.
PubMed 40420258
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Occlusal Force Distribution and Digital Occlusal Analysis Methods of Single Posterior Implant Restorations and Digital Occlusal Analysis Methods
- ClinicalTrials.gov ID
- NCT06862973
- Acronym / sponsor ID
- 20754
- Conditions
- Occlusal Analysis
- Keywords
- Occlusion, Dental Implant, Occlusal Analysis, OccluSense, Medit i700
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 7 Mar 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.
This study will explore the impact of single tooth implant restorations upon occlusal force distribution and the accuracy of several digital analysis methods. The biomechanical behavior of implant-supported prostheses differs from that of natural teeth, and the distribution and modulation of occlusal forces are unpredictable.
The research used the Medit i700 intraoral scanner and the OccluSense system to take pre- and post-implant measurements. The research aims to determine: How are the techniques different in the registration of occlusal contacts and force magnitude? and How does occlusal balance shift following the placement of an implant? The research findings can be used to provide clinical recommendations to optimize occlusal balancing during implant prosthetics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- he study population consists of adult patients requiring single posterior implant-supported restorations at Necmettin Erbakan University Faculty of Dentistry. Participants are selected based on specific inclusion criteria, including good periodontal health, a single missing tooth in the posterior region, and stable occlusion (Class I bite). Patients with a history of temporomandibular joint disorders, acute pain, occlusal dysfunction, restricted mouth opening, or prior orthodontic or surgical treatments affecting occlusion are excluded. The study aims to assess occlusal force distribution changes in a clinically relevant population undergoing implant rehabilitation, providing insights into post-restorative occlusal adjustments.
Key inclusion criteria (4 listed)
- Individuals aged 18 and over
- Patients with good periodontal health
- Patients with a Class I bite
- Patients with a single tooth deficiency in the posterior region planned for rehabilitation with an implant-supported single crown restoration
Key exclusion criteria (5 listed)
- History of temporomandibular joint disease
- Acute pain or signs of occlusal dysfunction
- Restricted mouth opening
- Absence of a tooth distal to the planned restoration
- Occlusion instability due to prior orthodontic or surgical treatments
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 |
|---|---|---|
| Digital Occlusal Analysis Using Medit i700 and OccluSense in Single-Tooth Implant RestorationsThis study differs from other research through the comparison of two advanced digital occlusal analysis methods-OccluSense system and MEDIT i700 intraoral scanner-to measure occlusal force distribution both before and after the insertion of single-tooth implant restorations in the posterior segment. Unlike research based upon the use of articulation paper, this study employs pressure-sensitive sensor technology (OccluSense) and scanner-based occlusion analysis (MEDIT i700) to quantitatively measure occlusal contacts and force intensity using CloudCompare and ImageJ. With the analysis of the variations that take place within the pre-and-post implant occlusion, the study provides an understanding of occlusal adaptation and how to optimize occlusal adjustments to prevent implant overload and complications, differing from the research that has previously lacked both digital force mapping and longitudinal occlusal analysis. | Diagnostic test | – |
Primary outcome
Change in Occlusal Force Distribution from Pre-Implant to Post-Implant Restoration as Measured by Medit i700 and OccluSense
Time frame: From pre-implant assessment to 2 week after final implant restoration placement.
Occlusal force distribution was measured before and after single-tooth implant restoration using two digital occlusal analysis methods: Medit i700 intraoral scanner and OccluSense pressure sensor system. Measurements were taken under standardized conditions, ensuring maximum intercuspation position. Medit i700 provided contact area data through intraoral scans, analyzed with CloudCompare software, while OccluSense recorded occlusal force intensity and distribution, analyzed with ImageJ software. The percentage change in occlusal contact areas and force distribution was calculated between the pre- and post-implant conditions. A statistically significant change (p < 0.05) indicates an alteration in occlusal balance following the restoration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 40420258Gozen M, Guntekin N. Comparison of occlusal force distribution and digital occlusal analysis methods of single posterior implant restorations: an in vivo study. BMC Oral Health. 2025 May 26;25(1):795. doi: 10.1186/s12903-025-06205-w.
- Individual participant dataSharing planned: Yes. yes, all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Occlusal Analysis, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Occlusal Force Distribution from Pre-Implant to Post-Implant Restoration as Measured by Medit i700 and OccluSense (time frame: From pre-implant assessment to 2 week after final implant restoration placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862973, which also lists 1 linked publication.
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 10 Mar 2025.