NCT03415971

Brief Summary

The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 28, 2016

Last Update Submit

January 23, 2018

Conditions

EdentulousTeeth ReplacementBounded Edentulous Space

Outcome Measures

Primary Outcomes (1)

  • The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.

    The present study demonstrated that Osseo Speed implants are safe and reasonable way of treatment for partial tooth loss in the lateral side. There was observed healthy soft tissue and marginal bone stability around the implants. Received data analysis using surface EMG allow to assume than functional state of maxillofacial region and neuromuscular coordination of the muscles of mastication in patients with bounded edentulous space in the lateral side (molars and/or premolars) with implant-supported prosthesis is considerably better than in patients with fixed bridges. Implant-supported prosthesis provide greater bite force for chewing function in comparison with fixed bridges , but certainly less effective than natural teeth. Implant-supported prosthesis increase patients' quality of life and is more convenient for dentoalveolar apparatus.

    up to 3 months.

Study Arms (3)

ASTRA TECH implants

ACTIVE COMPARATOR

implant restoration(replace of a missing tooth) - 35 patients

Procedure: EMG befor denture treatmentProcedure: EMG in a month after termination of treatmentProcedure: EMG in a 3 months after termination of treatment

CROWN

ACTIVE COMPARATOR

to fixed denture restorations in own teeth - 32 patients

Procedure: EMG befor denture treatmentProcedure: EMG in a month after termination of treatmentProcedure: EMG in a 3 months after termination of treatment

non-edontulos

PLACEBO COMPARATOR

control group will consist 38 non-edotulos patients

Procedure: EMG befor denture treatment

Interventions

EMG befor denture treatmentPROCEDURE
Also known as: electromyographia
ASTRA TECH implantsCROWNnon-edontulos
EMG in a month after termination of treatmentPROCEDURE
Also known as: electromyographia
ASTRA TECH implantsCROWN
EMG in a 3 months after termination of treatmentPROCEDURE
Also known as: electromyographia
ASTRA TECH implantsCROWN

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
  • Patients ages 20-45 y.o.

You may not qualify if:

  • Chronical third-degree cardiac failure
  • Connective tissue diseases
  • Decompensated diabetes
  • Neoplastic processes
  • Strokes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2016

First Posted

January 30, 2018

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 23, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01