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

N/ACompletedNCT01961635

Implantology Institute60 enrolled

Overview

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 ?

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bone Loss Inflammation

Interventions

dental implantsDEVICE

place implant according fabricant guidelines, 2mm sub-crestally

Zirconia abutmentsDEVICE

place zirconia abutment on the day of implant placement

Titanium AbutmentsDEVICE

place titanium abutment on the day of implant placement

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculdade de Medicina Dentária de Lisboa

Lisbon, Portugal

Outcomes

Primary Outcomes

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

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 Outcomes

Marginal Bone Loss

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

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

Time frame: 12 weeks post-implant installation

Osseointegration

compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments

Time frame: 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

Time frame: 12 weeks post implant installation

Data from ClinicalTrials.gov

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