NCT02090647

Brief Summary

The objective of the study was to assess the aesthetic outcome of different abutments materials and shapes on dental implants . A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of the aesthetic of implant-prosthesis rehabilitations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

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

January 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

March 14, 2014

Last Update Submit

March 14, 2014

Conditions

Aesthetic EvaluationImplant Survival Rate

Keywords

dental implant, aesthetic, implant abutment

Outcome Measures

Primary Outcomes (1)

  • aesthetic evaluation

    measure of how the implant-prosthesis restoration is able to comply with the color, shape and proportions imitating as much as possible natural dentition.

    12 months

Secondary Outcomes (1)

  • implant survival rate

    12 months

Study Arms (5)

titanium 1

ACTIVE COMPARATOR

titanium abutment type 1

Behavioral: aesthetic outcome

titanium 2

ACTIVE COMPARATOR

titanium abutment type 2

Behavioral: aesthetic outcome

zirconia 1

ACTIVE COMPARATOR

zirconia abutment type 1

Behavioral: aesthetic outcome

zirconia 2

ACTIVE COMPARATOR

zirconia abutment type 2

Behavioral: aesthetic outcome

titanium nitrate

ACTIVE COMPARATOR

titanium nitrate abutment

Behavioral: aesthetic outcome

Interventions

aesthetic outcomeBEHAVIORAL
titanium 1titanium 2titanium nitratezirconia 1zirconia 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged over 18 years
  • dental implant rehabilitation requested
  • at least 1 tooth missing in areas between 1.5-3.5 and 3.5-4.5
  • sufficient bone volume for implant placement ( length 10-15mm; diameter 2.5-4mm, bone quality between class I and III of Lekholm and Zarb).
  • informed consensus acceptance

You may not qualify if:

  • systemic pathologies that represent controindication to implantology
  • smoking (more than 10 cigarettes per day)
  • severe bruxism
  • untreated periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dental Materials and Fixed Prosthodontics of the University of Siena, Policlinico Le Scotte

Siena, Siena, 53100, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 18, 2014

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

IT(1)