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

Not Applicable

Completed

• Conditions: Bone Loss; Inflammation

• 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

Study Timeline

• Study First Submitted: 2013-10-06
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Study Start: 2016-01
• Primary Completion: 2017-03-23
• Study Completion: 2017-03-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-29
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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

Trial Locations

Locations (1)

Faculdade de Medicina Dentária de Lisboa; 🇵🇹 Lisbon, Portugal