NCT05083715

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 5, 2021

Last Update Submit

October 21, 2021

Conditions

Keywords

dental occlusionhead posturefixed dental restorationsdental implantsimplant occlusioncomputerized occlusal analysis

Outcome Measures

Primary Outcomes (2)

  • Changes in occlusal contacts distribution in 3 different head positions

    Computerized occlusal analysis

    Baseline-1 year

  • Changes in relative forces strength in 3 different head positions

    Computerized occlusal analysis

    Baseline-1 year

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Prosthodontics, University of Belgrade Serbia

Belgrade, 11000, Serbia

Location

Related Publications (4)

  • 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.

    PMID: 33783094BACKGROUND
  • Sadowsky 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.

    PMID: 31332553BACKGROUND
  • Afrashtehfar 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.

    PMID: 25323220BACKGROUND
  • Chapman RJ, Maness WL, Osorio J. Occlusal contact variation with changes in head position. Int J Prosthodont. 1991 Jul-Aug;4(4):377-81.

    PMID: 1811633BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Ana R Todorovic, DDS,PhD

    Clinic for Prosthodontics, University of Belgrade Serbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 19, 2021

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 10, 2019

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations