NCT01961635

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 ?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

October 6, 2013

Last Update Submit

April 29, 2017

Conditions

Bone LossInflammation

Keywords

Dental ImplantsZirconia AbutmentsTitanium abutmentsAcrylic abutmentsGingival HealingInflammationBone loss

Outcome Measures

Primary Outcomes (1)

  • 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

    Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks

Secondary Outcomes (4)

  • Marginal Bone Loss

    measured at 12 weeks post-implant installation

  • Gingival height

    12 weeks post-implant installation

  • Osseointegration

    12 weeks post-implant installation

  • Height from gingiva to abutment

    12 weeks post implant installation

Study Arms (3)

Zirconia Abutments

EXPERIMENTAL

Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2

Device: dental implantsDevice: Zirconia abutmentsProcedure: SubcrestalDevice: platform-switchProcedure: one-time one-abutmentProcedure: Torque 20 n/cm2

Titanium Abutments

EXPERIMENTAL

Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2

Device: dental implantsDevice: Titanium AbutmentsProcedure: SubcrestalDevice: platform-switchProcedure: one-time one-abutmentProcedure: Torque 20 n/cm2

Cad-Cam Acrylic abutments

EXPERIMENTAL

Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2

Device: dental implantsDevice: cad-cam acrylic abutmentsProcedure: SubcrestalDevice: platform-switchProcedure: one-time one-abutmentProcedure: Torque 20 n/cm2

Interventions

dental implantsDEVICE

place implant according fabricant guidelines, 2mm sub-crestally

Also known as: T3 - Biomet 3I Implants, Platform-Switch 4.1, Abutment Diameter 3.25
Cad-Cam Acrylic abutmentsTitanium AbutmentsZirconia Abutments
Zirconia abutmentsDEVICE

place zirconia abutment on the day of implant placement

Also known as: Zirconia cad-cam abutment, 3.25 Abutment connection
Zirconia Abutments
Titanium AbutmentsDEVICE

place titanium abutment on the day of implant placement

Also known as: Titanium Encode - biomet 3I Implants, 3,25 abutment connection
Titanium Abutments
cad-cam acrylic abutmentsDEVICE

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

Also known as: Cad-cam acrylic abutment, 3.25 platform
Cad-Cam Acrylic abutments
SubcrestalPROCEDURE

place implant 2mm below crestal bone

Cad-Cam Acrylic abutmentsTitanium AbutmentsZirconia Abutments
platform-switchDEVICE

abutment platform is narrow than implant diameter

Cad-Cam Acrylic abutmentsTitanium AbutmentsZirconia Abutments
one-time one-abutmentPROCEDURE

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

Also known as: one time abutment, final abutment on the day of surgery
Cad-Cam Acrylic abutmentsTitanium AbutmentsZirconia Abutments
Torque 20 n/cm2PROCEDURE

the amount of torque applied to the abutment

Also known as: manual torque
Cad-Cam Acrylic abutmentsTitanium AbutmentsZirconia Abutments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina Dentária de Lisboa

Lisbon, 1500-662, Portugal

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicInflammation

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • João Caramês, Phd

    Faculdade de Medicina Dentária de Lisboa

    PRINCIPAL INVESTIGATOR

  • André Chen Chen, Msc

    Faculdade de Medicina Dentária de Lisboa

    STUDY DIRECTOR

  • Elena Cervino, Msc

    Implantology Institute

    STUDY CHAIR

  • Helena Francisco, Phd

    Faculdade de Medicina Dentária de Lisboa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 11, 2013

Study Start

January 1, 2016

Primary Completion

March 23, 2017

Study Completion

March 23, 2017

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

PT(1)