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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Bone Loss, Inflammation

Intervention / Treatment
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* Device: dental implants
* Device: Zirconia abutments
* Device: Titanium Abutments
* Device: cad-cam acrylic abutments
* Procedure: Subcrestal
* Device: platform-switch
* Procedure: one-time one-abutment
* Procedure: Torque 20 n/cm2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zirconia Abutments<br>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<br>* place implant according fabricant guidelines, 2mm sub-crestally<br>* Other names: Abutment Diameter 3.25;Device: Zirconia abutments<br>* place zirconia abutment on the day of implant placement<br>* Other names: 3.25 Abutment connection;Procedure: Subcrestal<br>* place implant 2mm below crestal bone<br>Device: platform-switch<br>* abutment platform is narrow than implant diameter<br>Procedure: one-time one-abutment<br>* place the final abutment on the day of surgery and not remove it<br>* Other names: final abutment on the day of surgery;Procedure: Torque 20 n/cm2<br>* the amount of torque applied to the abutment<br>* Other names: manual torque;|
| Experimental: Titanium Abutments<br>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<br>* place implant according fabricant guidelines, 2mm sub-crestally<br>* Other names: Abutment Diameter 3.25;Device: Titanium Abutments<br>* place titanium abutment on the day of implant placement<br>* Other names: 3,25 abutment connection;Procedure: Subcrestal<br>* place implant 2mm below crestal bone<br>Device: platform-switch<br>* abutment platform is narrow than implant diameter<br>Procedure: one-time one-abutment<br>* place the final abutment on the day of surgery and not remove it<br>* Other names: final abutment on the day of surgery;Procedure: Torque 20 n/cm2<br>* the amount of torque applied to the abutment<br>* Other names: manual torque;|
| Experimental: Cad-Cam Acrylic abutments<br>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<br>* place implant according fabricant guidelines, 2mm sub-crestally<br>* Other names: Abutment Diameter 3.25;Device: cad-cam acrylic abutments<br>* place cad-cam acrylic abutment on the day of implant placement<br>* Other names: 3.25 platform;Procedure: Subcrestal<br>* place implant 2mm below crestal bone<br>Device: platform-switch<br>* abutment platform is narrow than implant diameter<br>Procedure: one-time one-abutment<br>* place the final abutment on the day of surgery and not remove it<br>* Other names: final abutment on the day of surgery;Procedure: Torque 20 n/cm2<br>* the amount of torque applied to the abutment<br>* Other names: manual torque;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implants, Zirconia Abutments, Titanium abutments, Acrylic abutments, Gingival Healing, Inflammation, Bone loss