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Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
implant insertion and abutment connection
Sponsored by
Proed, Torino, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Osseointegrated Implant, Bone level

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy adult patients with partial edentulism

Exclusion Criteria:

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

Sites / Locations

  • PROED, Institute for Professional Education in Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

standard platform , standard abutment

standard platform, flat abutment

switching platform, standard abutment

switching platform, flat abutment

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Probing Pocket Depth
Probing depth measured mesially, buccaly, distally and lingually at implant site
Bleeding on Probing
Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site

Full Information

First Posted
March 7, 2013
Last Updated
September 1, 2016
Sponsor
Proed, Torino, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01807416
Brief Title
Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
Official Title
Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proed, Torino, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
BACKGROUND: Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar). Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided. MATERIALS & METHODS: 80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. 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 The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Osseointegrated Implant, Bone level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard platform , standard abutment
Arm Type
Active Comparator
Arm Description
implant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments
Arm Title
standard platform, flat abutment
Arm Type
Active Comparator
Arm Description
implant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments
Arm Title
switching platform, standard abutment
Arm Type
Active Comparator
Arm Description
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments
Arm Title
switching platform, flat abutment
Arm Type
Active Comparator
Arm Description
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments
Intervention Type
Procedure
Intervention Name(s)
implant insertion and abutment connection
Intervention Description
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Primary Outcome Measure Information:
Title
Marginal Bone Level
Description
On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured
Time Frame
1 year after implant installation
Secondary Outcome Measure Information:
Title
Probing Pocket Depth
Description
Probing depth measured mesially, buccaly, distally and lingually at implant site
Time Frame
1 year after implant installation
Title
Bleeding on Probing
Description
Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site
Time Frame
1 year after implant installation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy adult patients with partial edentulism Exclusion Criteria: Current pregnant patients History of malignancy History of radiotherapy or chemiotherapy in the last 5 years Long term steroidal or antibiotic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Cardaropoli, DDS
Organizational Affiliation
Proed, Torino, Italy
Official's Role
Study Director
Facility Information:
Facility Name
PROED, Institute for Professional Education in Dentistry
City
Torino
State/Province
TO
ZIP/Postal Code
10129
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

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