Bone Loss, Inflammation
Conditions
Keywords
Dental Implants, Zirconia Abutments, Titanium abutments, Acrylic abutments, Gingival Healing, Inflammation, Bone loss
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
Interventions
PROCEDUREone-time one-abutment
place the final abutment on the day of surgery and not remove it
DEVICEdental implants
place implant according fabricant guidelines, 2mm sub-crestally
DEVICEZirconia abutments
place zirconia abutment on the day of implant placement
DEVICETitanium Abutments
place titanium abutment on the day of implant placement
DEVICEcad-cam acrylic abutments
place cad-cam acrylic abutment on the day of implant placement
PROCEDURESubcrestal
place implant 2mm below crestal bone
DEVICEplatform-switch
abutment platform is narrow than implant diameter
PROCEDURETorque 20 n/cm2
the amount of torque applied to the abutment
Sponsors
Implantology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Portugal
Outcome results
None listed