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Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss

Primary Purpose

Bone Loss, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
dental implants
Zirconia abutments
Titanium Abutments
cad-cam acrylic abutments
Subcrestal
platform-switch
one-time one-abutment
Torque 20 n/cm2
Sponsored by
Implantology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring Dental Implants, Zirconia Abutments, Titanium abutments, Acrylic abutments, Gingival Healing, Inflammation, Bone loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Single unit implant rehabilitation
  • Maxilla and mandible
  • Must accept treatment plan
  • Must sign informed consent
  • dental extraction performed at least 3 month prior
  • Must have at least 6 mm of residual bone
  • Absence of oral lesions
  • keratinized tissue must be present

Exclusion Criteria:

  • If smoking and/or other drug addiction is present
  • If local anesthetic allergy is present
  • Patient subjected to chemical or radiotherapy
  • if Hepatic disease is present
  • If immunodepression is present
  • If Pregnancy is present
  • If Diabetes is present
  • If Heart disease is present

Sites / Locations

  • Faculdade de Medicina Dentária de Lisboa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Zirconia Abutments

Titanium Abutments

Cad-Cam Acrylic abutments

Arm Description

Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2

Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2

Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2

Outcomes

Primary Outcome Measures

Gingival Inflammatory Changes from baseline to 12 weeks
measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic

Secondary Outcome Measures

Marginal Bone Loss
Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic
Gingival height
measure with periodontal probe distance from implant platform to the most coronal point of gingival margin mesial, distal, buccal and lingual,in zirconia,titanium, acrylic, and cad-cam acrylic
Osseointegration
compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments
Height from gingiva to abutment
height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments

Full Information

First Posted
October 6, 2013
Last Updated
April 29, 2017
Sponsor
Implantology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01961635
Brief Title
Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss
Official Title
Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Implantology Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?
Detailed Description
Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Inflammation
Keywords
Dental Implants, Zirconia Abutments, Titanium abutments, Acrylic abutments, Gingival Healing, Inflammation, Bone loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zirconia Abutments
Arm Type
Experimental
Arm Description
Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
Arm Title
Titanium Abutments
Arm Type
Experimental
Arm Description
Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
Arm Title
Cad-Cam Acrylic abutments
Arm Type
Experimental
Arm Description
Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
Intervention Type
Device
Intervention Name(s)
dental implants
Other Intervention Name(s)
T3 - Biomet 3I Implants, Platform-Switch 4.1, Abutment Diameter 3.25
Intervention Description
place implant according fabricant guidelines, 2mm sub-crestally
Intervention Type
Device
Intervention Name(s)
Zirconia abutments
Other Intervention Name(s)
Zirconia cad-cam abutment, 3.25 Abutment connection
Intervention Description
place zirconia abutment on the day of implant placement
Intervention Type
Device
Intervention Name(s)
Titanium Abutments
Other Intervention Name(s)
Titanium Encode - biomet 3I Implants, 3,25 abutment connection
Intervention Description
place titanium abutment on the day of implant placement
Intervention Type
Device
Intervention Name(s)
cad-cam acrylic abutments
Other Intervention Name(s)
Cad-cam acrylic abutment, 3.25 platform
Intervention Description
place cad-cam acrylic abutment on the day of implant placement
Intervention Type
Procedure
Intervention Name(s)
Subcrestal
Intervention Description
place implant 2mm below crestal bone
Intervention Type
Device
Intervention Name(s)
platform-switch
Intervention Description
abutment platform is narrow than implant diameter
Intervention Type
Procedure
Intervention Name(s)
one-time one-abutment
Other Intervention Name(s)
one time abutment, final abutment on the day of surgery
Intervention Description
place the final abutment on the day of surgery and not remove it
Intervention Type
Procedure
Intervention Name(s)
Torque 20 n/cm2
Other Intervention Name(s)
manual torque
Intervention Description
the amount of torque applied to the abutment
Primary Outcome Measure Information:
Title
Gingival Inflammatory Changes from baseline to 12 weeks
Description
measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic
Time Frame
Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks
Secondary Outcome Measure Information:
Title
Marginal Bone Loss
Description
Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic
Time Frame
measured at 12 weeks post-implant installation
Title
Gingival height
Description
measure with periodontal probe distance from implant platform to the most coronal point of gingival margin mesial, distal, buccal and lingual,in zirconia,titanium, acrylic, and cad-cam acrylic
Time Frame
12 weeks post-implant installation
Title
Osseointegration
Description
compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments
Time Frame
12 weeks post-implant installation
Title
Height from gingiva to abutment
Description
height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments
Time Frame
12 weeks post implant installation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Single unit implant rehabilitation Maxilla and mandible Must accept treatment plan Must sign informed consent dental extraction performed at least 3 month prior Must have at least 6 mm of residual bone Absence of oral lesions keratinized tissue must be present Exclusion Criteria: If smoking and/or other drug addiction is present If local anesthetic allergy is present Patient subjected to chemical or radiotherapy if Hepatic disease is present If immunodepression is present If Pregnancy is present If Diabetes is present If Heart disease is present
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Caramês, Phd
Organizational Affiliation
Faculdade de Medicina Dentária de Lisboa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
André Chen Chen, Msc
Organizational Affiliation
Faculdade de Medicina Dentária de Lisboa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elena Cervino, Msc
Organizational Affiliation
Implantology Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helena Francisco, Phd
Organizational Affiliation
Faculdade de Medicina Dentária de Lisboa
Official's Role
Study Chair
Facility Information:
Facility Name
Faculdade de Medicina Dentária de Lisboa
City
Lisbon
ZIP/Postal Code
1500-662
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss

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