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OpenTrials
Completed

NCT Number: NCT01961635

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

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 ?

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Inflammation Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Medicina Dentária de Lisboa

Lisbon, 1500-662, Portugal

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental implants

Device

place implant according fabricant guidelines, 2mm sub-crestally

Other names: T3 - Biomet 3I Implants, Platform-Switch 4.1, Abutment Diameter 3.25

Zirconia abutments

Device

place zirconia abutment on the day of implant placement

Other names: Zirconia cad-cam abutment, 3.25 Abutment connection

Titanium Abutments

Device

place titanium abutment on the day of implant placement

Other names: Titanium Encode - biomet 3I Implants, 3,25 abutment connection

cad-cam acrylic abutments

Device

place cad-cam acrylic abutment on the day of implant placement

Other names: Cad-cam acrylic abutment, 3.25 platform

Subcrestal

Procedure

place implant 2mm below crestal bone

platform-switch

Device

abutment platform is narrow than implant diameter

one-time one-abutment

Procedure

place the final abutment on the day of surgery and not remove it

Other names: one time abutment, final abutment on the day of surgery

Torque 20 n/cm2

Procedure

the amount of torque applied to the abutment

Other names: manual torque

Primary outcomes

  1. Gingival Inflammatory Changes from baseline to 12 weeks

    Time frame: 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 outcomes

  1. Marginal Bone Loss

    Time frame: 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

  2. Gingival height

    Time frame: 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

  3. Osseointegration

    Time frame: 12 weeks post-implant installation

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

  4. Height from gingiva to abutment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Implantology Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 11, 2013
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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