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

Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial

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 ?

Study Overview

• Status: Completed
• Conditions: Inflammation; Bone Loss
• Intervention / Treatment: Device: dental implants; Device: Zirconia abutments; Procedure: Subcrestal; Device: platform-switch; Procedure: one-time one-abutment; Procedure: Torque 20 n/cm2; Device: Titanium Abutments; Device: cad-cam acrylic abutments

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1500-662
    • Faculdade de Medicina Dentária de Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zirconia Abutments; Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2	Device: dental implants; place implant according fabricant guidelines, 2mm sub-crestally; Other Names: T3 - Biomet 3I Implants; Platform-Switch 4.1; Abutment Diameter 3.25; Device: Zirconia abutments; place zirconia abutment on the day of implant placement; Other Names: Zirconia cad-cam abutment; 3.25 Abutment connection; Procedure: Subcrestal; place implant 2mm below crestal bone; Device: platform-switch; abutment platform is narrow than implant diameter; Procedure: one-time one-abutment; place the final abutment on the day of surgery and not remove it; Other Names: one time abutment; final abutment on the day of surgery; Procedure: Torque 20 n/cm2; the amount of torque applied to the abutment; Other Names: manual torque
Experimental: Titanium Abutments; Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2	Device: dental implants; place implant according fabricant guidelines, 2mm sub-crestally; Other Names: T3 - Biomet 3I Implants; Platform-Switch 4.1; Abutment Diameter 3.25; Procedure: Subcrestal; place implant 2mm below crestal bone; Device: platform-switch; abutment platform is narrow than implant diameter; Procedure: one-time one-abutment; place the final abutment on the day of surgery and not remove it; Other Names: one time abutment; final abutment on the day of surgery; Procedure: Torque 20 n/cm2; the amount of torque applied to the abutment; Other Names: manual torque; Device: Titanium Abutments; place titanium abutment on the day of implant placement; Other Names: Titanium Encode - biomet 3I Implants; 3,25 abutment connection
Experimental: Cad-Cam Acrylic abutments; Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2	Device: dental implants; place implant according fabricant guidelines, 2mm sub-crestally; Other Names: T3 - Biomet 3I Implants; Platform-Switch 4.1; Abutment Diameter 3.25; Procedure: Subcrestal; place implant 2mm below crestal bone; Device: platform-switch; abutment platform is narrow than implant diameter; Procedure: one-time one-abutment; place the final abutment on the day of surgery and not remove it; Other Names: one time abutment; final abutment on the day of surgery; Procedure: Torque 20 n/cm2; the amount of torque applied to the abutment; Other Names: manual torque; Device: cad-cam acrylic abutments; place cad-cam acrylic abutment on the day of implant placement; Other Names: Cad-cam acrylic abutment; 3.25 platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss	Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic	measured at 12 weeks post-implant installation
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	12 weeks post-implant installation
Osseointegration	compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments	12 weeks post-implant installation
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	12 weeks post implant installation

Collaborators and Investigators

• Sponsor: Implantology Institute
• Investigators: Principal Investigator: João Caramês, Phd, Faculdade de Medicina Dentária de Lisboa; Study Director: André Chen Chen, Msc, Faculdade de Medicina Dentária de Lisboa; Study Chair: Helena Francisco, Phd, Faculdade de Medicina Dentária de Lisboa

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 23, 2017
• Study Completion (Actual): March 23, 2017

Study Registration Dates

• First Submitted: October 6, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 29, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Inflammation; Dental Implants; Bone loss; Zirconia Abutments; Titanium abutments; Acrylic abutments; Gingival Healing
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED