The Impact of the Head Position on the Occlusion of Implant-supported Fixed Restorations (TIOTHPOTO)

October 21, 2021 updated by: Ana Todorovic, University of Belgrade

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

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

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for Prosthodontics, University of Belgrade Serbia

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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).

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in occlusal contacts distribution in 3 different head positions
Time Frame: Baseline-1 year
Computerized occlusal analysis
Baseline-1 year
Changes in relative forces strength in 3 different head positions
Time Frame: Baseline-1 year
Computerized occlusal analysis
Baseline-1 year

Collaborators and Investigators

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

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Ana R Todorovic, DDS,PhD, Clinic for Prosthodontics, University of Belgrade Serbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2017

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 10, 2019

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Univerzitet Beograd

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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