Dental OcclusionTIOTHPOTONCT05083715
The Impact of the Head Position on the Occlusion of Implant-supported Fixed Restorations
An observational study of Dental Occlusion, run by University of Belgrade at 1 site in Serbia.
Trial summary
The development of a implantology leads to an increasing use of implants in the treatment of care for the loss of one or more teeth. The question is whether the existing guidelines, originally formulated for the occlusion of natural dentition and conventional prosthetic treatment can be applied to the implant… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Occlusion
- How many people
- 31 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Sep 2017to 10 Sep 2019
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who refered to the Clinic for Prosthodontics due to the lack of one or more teeth that need to be replaced with dental implants and healthy completely dentate volunteers.
Who may be able to join
- For the Test Group
- patients with implant-supported fixed restorations in at least one quadrant of the posterior region (pre-molar and molar) of both jaws at least for 1 year
- patients with Angle Class I in MIP
- patients who did not have orthodontic treatment
- For the Control group, the inclusion criteria were:
- patients with completely dentate arches (not considering third molars) with a maximum of 4 tooth-supported restorations per dental arch).
Who cannot join
- patients with bruxism, detrimental habits, and mandibular parafunctional activities
- patients with signs of temporomandibular dysfunction, trismus, or illness of the cervical spine
- patients with a history indicating problems with alcohol or drugs or receiving any psychiatric treatment.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for Prosthodontics, University of Belgrade Serbia
Belgrade, 11000
About this study
Official title: The Impact of the Head Position on the Occlusion of Implant-supported Fixed Restorations vs. Natural Dentition - a Cross-sectional Analysis
The development of a implantology leads to an increasing use of implants in the treatment of care for the loss of one or more teeth. The question is whether the existing guidelines, originally formulated for the occlusion of natural dentition and conventional prosthetic treatment can be applied to the implant prosthodonticsDue to initial differences in the vertical mobility of teeth and dental implants, present in the same dental arch, although the model of occlusion is ideal, undesirable premature occlusal contacts on the fixed dental restorations on implants may be present.
Objective: To evaluate the effect of different head positions on dental occlusion of the natural teeth and fixed dental restorations on implants.
Methods: Volunteers with complete dentition would be included in this study as the Control Group. The Study Group would include subjects with fixed dental restorations on implants in the transcanine region. A T Scan III System will be used for occlusal analysis.
- Conditions
- Dental Occlusion
- Keywords
- dental occlusion, head posture, fixed dental restorations, dental implants, implant occlusion, computerized occlusal analysis
- Medical subject headings
- Bites and Stings
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in occlusal contacts distribution in 3 different head positions
Computerized occlusal analysis
Measured: Baseline-1 year
Changes in relative forces strength in 3 different head positions
Computerized occlusal analysis
Measured: Baseline-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Sep 2017
- Primary completion1 Sep 2018
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental OcclusionStudies 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
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Todorovic, University of Belgrade
- Investigators
- Ana R Todorovic, DDS,PhD, Principal investigator, Clinic for Prosthodontics, University of Belgrade Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083715
- Sponsor's protocol ID
- Univerzitet Beograd
- Acronym
- TIOTHPOTO
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldstein G, Goodacre C, Taylor T. Occlusal Schemes for Implant Restorations: Best Evidence Consensus Statement. J Prosthodont. 2021 Apr;30(S1):84-90. doi: 10.1111/jopr.13319.
PubMed 33783094Sadowsky SJ. Occlusal overload with dental implants: a review. Int J Implant Dent. 2019 Jul 23;5(1):29. doi: 10.1186/s40729-019-0180-8.
PubMed 31332553Afrashtehfar KI, Qadeer S. Computerized occlusal analysis as an alternative occlusal indicator. Cranio. 2016 Jan;34(1):52-7. doi: 10.1179/2151090314Y.0000000024. Epub 2014 Oct 16.
PubMed 25323220Chapman RJ, Maness WL, Osorio J. Occlusal contact variation with changes in head position. Int J Prosthodont. 1991 Jul-Aug;4(4):377-81.
PubMed 1811633
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Head Position on the Occlusion of Implant-supported Fixed Restorations vs. Natural Dentition - a Cross-sectional Analysis
- ClinicalTrials.gov ID
- NCT05083715
- Acronym / sponsor ID
- TIOTHPOTO / Univerzitet Beograd
- Conditions
- Dental Occlusion
- Keywords
- dental occlusion, head posture, fixed dental restorations, dental implants, implant occlusion, computerized occlusal analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 19 Oct 2021 (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 development of a implantology leads to an increasing use of implants in the treatment of care for the loss of one or more teeth. The question is whether the existing guidelines, originally formulated for the occlusion of natural dentition and conventional prosthetic treatment can be applied to the implant prosthodonticsDue to initial differences in the vertical mobility of teeth and dental implants, present in the same dental arch, although the model of occlusion is ideal, undesirable premature occlusal contacts on the fixed dental restorations on implants may be present.
Objective: To evaluate the effect of different head positions on dental occlusion of the natural teeth and fixed dental restorations on implants.
Methods: Volunteers with complete dentition would be included in this study as the Control Group. The Study Group would include subjects with fixed dental restorations on implants in the transcanine region. A T Scan III System will be used for occlusal analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who refered to the Clinic for Prosthodontics due to the lack of one or more teeth that need to be replaced with dental implants and healthy completely dentate volunteers.
Key inclusion criteria (6 listed)
- For the Test Group
- patients with implant-supported fixed restorations in at least one quadrant of the posterior region (pre-molar and molar) of both jaws at least for 1 year
- patients with Angle Class I in MIP
- patients who did not have orthodontic treatment
- patients with completely dentate arches (not considering third molars) with a maximum of 4 tooth-supported restorations per dental arch).
Key exclusion criteria (3 listed)
- patients with bruxism, detrimental habits, and mandibular parafunctional activities
- patients with signs of temporomandibular dysfunction, trismus, or illness of the cervical spine
- patients with a history indicating problems with alcohol or drugs or receiving any psychiatric treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in occlusal contacts distribution in 3 different head positions
Time frame: Baseline-1 year
Computerized occlusal analysis
Changes in relative forces strength in 3 different head positions
Time frame: Baseline-1 year
Computerized occlusal analysis
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 29 Oct 2021.
- Background: PubMed 33783094Goldstein G, Goodacre C, Taylor T. Occlusal Schemes for Implant Restorations: Best Evidence Consensus Statement. J Prosthodont. 2021 Apr;30(S1):84-90. doi: 10.1111/jopr.13319.
- Background: PubMed 31332553Sadowsky SJ. Occlusal overload with dental implants: a review. Int J Implant Dent. 2019 Jul 23;5(1):29. doi: 10.1186/s40729-019-0180-8.
- Background: PubMed 25323220Afrashtehfar KI, Qadeer S. Computerized occlusal analysis as an alternative occlusal indicator. Cranio. 2016 Jan;34(1):52-7. doi: 10.1179/2151090314Y.0000000024. Epub 2014 Oct 16.
- Background: PubMed 1811633Chapman RJ, Maness WL, Osorio J. Occlusal contact variation with changes in head position. Int J Prosthodont. 1991 Jul-Aug;4(4):377-81.
- 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. This study is not recruiting at the moment.
Ana R Todorovic, DDS,PhD principal investigator
Clinic for Prosthodontics, University of Belgrade Serbia
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 Occlusion, run by University of Belgrade at 1 site in Serbia.
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 6 inclusion and 3 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 29 Oct 2021. 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 Serbia. 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?
Changes in occlusal contacts distribution in 3 different head positions (time frame: Baseline-1 year). The study lists 2 primary outcomes in all. 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 NCT05083715, which also lists 4 linked publications.
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 29 Oct 2021.