NCT01807416

Brief Summary

Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided. 80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion. Data will refer to the following timing: T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design. Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing. Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

March 7, 2013

Last Update Submit

September 1, 2016

Conditions

Jaw, Edentulous, Partially

Keywords

Osseointegrated Implant, Bone level

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Level

    On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured

    1 year after implant installation

Secondary Outcomes (2)

  • Probing Pocket Depth

    1 year after implant installation

  • Bleeding on Probing

    1 year after implant installation

Study Arms (4)

standard platform , standard abutment

ACTIVE COMPARATOR

implant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments

Procedure: implant insertion and abutment connection

standard platform, flat abutment

ACTIVE COMPARATOR

implant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments

Procedure: implant insertion and abutment connection

switching platform, standard abutment

ACTIVE COMPARATOR

implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments

Procedure: implant insertion and abutment connection

switching platform, flat abutment

ACTIVE COMPARATOR

implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments

Procedure: implant insertion and abutment connection

Interventions

implant insertion and abutment connectionPROCEDURE

After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected

standard platform , standard abutmentstandard platform, flat abutmentswitching platform, flat abutmentswitching platform, standard abutment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult patients with partial edentulism

You may not qualify if:

  • Current pregnant patients
  • History of malignancy
  • History of radiotherapy or chemiotherapy in the last 5 years
  • Long term steroidal or antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROED, Institute for Professional Education in Dentistry

Torino, TO, 10129, Italy

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Daniele Cardaropoli, DDS

    Proed, Torino, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

September 1, 2015

Last Updated

September 2, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)