Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss
- Conditions
- Bone LossInflammation
- Interventions
- Device: dental implantsDevice: Titanium AbutmentsDevice: cad-cam acrylic abutmentsDevice: Zirconia abutmentsProcedure: SubcrestalDevice: platform-switchProcedure: one-time one-abutmentProcedure: Torque 20 n/cm2
- Registration Number
- NCT01961635
- Lead Sponsor
- Implantology Institute
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Titanium Abutments Titanium Abutments Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Titanium Abutments platform-switch Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Cad-Cam Acrylic abutments 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 Cad-Cam Acrylic abutments Subcrestal Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Zirconia Abutments Zirconia abutments Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Zirconia Abutments platform-switch Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Titanium Abutments 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 Zirconia Abutments dental implants Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Titanium Abutments Subcrestal Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Cad-Cam Acrylic abutments dental implants Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Zirconia Abutments Subcrestal Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Zirconia Abutments one-time one-abutment Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Cad-Cam Acrylic abutments 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 Zirconia Abutments Torque 20 n/cm2 Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Titanium Abutments dental implants Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Titanium Abutments one-time one-abutment Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Cad-Cam Acrylic abutments platform-switch Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Cad-Cam Acrylic abutments one-time one-abutment Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
- Primary Outcome Measures
Name Time Method Gingival Inflammatory Changes from baseline to 12 weeks Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 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
Name Time Method Gingival height 12 weeks post-implant installation 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
Marginal Bone Loss measured at 12 weeks post-implant installation Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic
Osseointegration 12 weeks post-implant installation compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments
Height from gingiva to abutment 12 weeks post implant installation height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments
Trial Locations
- Locations (1)
Faculdade de Medicina Dentária de Lisboa
🇵🇹Lisbon, Portugal