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

NCT ID: NCT01961635

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-23

Brief Summary

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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

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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

Conditions

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Bone Loss Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Zirconia Abutments

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

Group Type EXPERIMENTAL

dental implants

Intervention Type DEVICE

place implant according fabricant guidelines, 2mm sub-crestally

Zirconia abutments

Intervention Type DEVICE

place zirconia abutment on the day of implant placement

Subcrestal

Intervention Type PROCEDURE

place implant 2mm below crestal bone

platform-switch

Intervention Type DEVICE

abutment platform is narrow than implant diameter

one-time one-abutment

Intervention Type PROCEDURE

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

Torque 20 n/cm2

Intervention Type PROCEDURE

the amount of torque applied to the abutment

Titanium Abutments

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

Group Type EXPERIMENTAL

dental implants

Intervention Type DEVICE

place implant according fabricant guidelines, 2mm sub-crestally

Titanium Abutments

Intervention Type DEVICE

place titanium abutment on the day of implant placement

Subcrestal

Intervention Type PROCEDURE

place implant 2mm below crestal bone

platform-switch

Intervention Type DEVICE

abutment platform is narrow than implant diameter

one-time one-abutment

Intervention Type PROCEDURE

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

Torque 20 n/cm2

Intervention Type PROCEDURE

the amount of torque applied to the abutment

Cad-Cam Acrylic abutments

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

Group Type EXPERIMENTAL

dental implants

Intervention Type DEVICE

place implant according fabricant guidelines, 2mm sub-crestally

cad-cam acrylic abutments

Intervention Type DEVICE

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

Subcrestal

Intervention Type PROCEDURE

place implant 2mm below crestal bone

platform-switch

Intervention Type DEVICE

abutment platform is narrow than implant diameter

one-time one-abutment

Intervention Type PROCEDURE

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

Torque 20 n/cm2

Intervention Type PROCEDURE

the amount of torque applied to the abutment

Interventions

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dental implants

place implant according fabricant guidelines, 2mm sub-crestally

Intervention Type DEVICE

Zirconia abutments

place zirconia abutment on the day of implant placement

Intervention Type DEVICE

Titanium Abutments

place titanium abutment on the day of implant placement

Intervention Type DEVICE

cad-cam acrylic abutments

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

Intervention Type DEVICE

Subcrestal

place implant 2mm below crestal bone

Intervention Type PROCEDURE

platform-switch

abutment platform is narrow than implant diameter

Intervention Type DEVICE

one-time one-abutment

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

Intervention Type PROCEDURE

Torque 20 n/cm2

the amount of torque applied to the abutment

Intervention Type PROCEDURE

Other Intervention Names

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T3 - Biomet 3I Implants Platform-Switch 4.1 Abutment Diameter 3.25 Zirconia cad-cam abutment 3.25 Abutment connection Titanium Encode - biomet 3I Implants 3,25 abutment connection Cad-cam acrylic abutment 3.25 platform one time abutment final abutment on the day of surgery manual torque

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Implantology Institute

OTHER

Sponsor Role lead

Responsible Party

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Andre Chen

Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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João Caramês, Phd

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina Dentária de Lisboa

André Chen Chen, Msc

Role: STUDY_DIRECTOR

Faculdade de Medicina Dentária de Lisboa

Elena Cervino, Msc

Role: STUDY_CHAIR

Implantology Institute

Helena Francisco, Phd

Role: STUDY_CHAIR

Faculdade de Medicina Dentária de Lisboa

Locations

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Faculdade de Medicina Dentária de Lisboa

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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II-01

Identifier Type: -

Identifier Source: org_study_id

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