Influence of the Implant Connection on Facial Tissues Maturation

NCT ID: NCT04160689

Last Updated: 2019-11-14

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

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-11-01

Brief Summary

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The substitution of a tooth with a fixture often induces undesired morphological changes, resulting in a deterioration of the aesthetic appearance. The purpose of this study is to compare the soft tissue behavior next to two different implant connections: 5° (group 1) and 35° hexed (group 2), conical, internal with switching platform design after 12 months of functional provisionalization

Detailed Description

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Conditions

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Bone Loss Periodontal Bone Loss Implant Tissue Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Anyridge (Mega'Gen, Korea) 5° conical internal hexed connection

Group Type ACTIVE_COMPARATOR

implantology

Intervention Type BIOLOGICAL

placing of implant

Group 2

Core (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style)

Group Type ACTIVE_COMPARATOR

implantology

Intervention Type BIOLOGICAL

placing of implant

Interventions

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implantology

placing of implant

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Missing teeth
* good oral hygiene
* good systemic health

Exclusion Criteria

* lactation
* pregnancy
* heavy smoking (more than 20 cigarettes/day)
* severe medical conditions that could affect periodontal health and peri-implant tissue response
* use of drugs correlated to periodontal hypertrophy
* bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Marco Farronato

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Insubria

Varese, , Italy

Site Status

Countries

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Italy

References

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Farronato D, Pasini PM, Manfredini M, Scognamiglio C, Orsina AA, Farronato M. Influence of the implant-abutment connection on the ratio between height and thickness of tissues at the buccal zenith: a randomized controlled trial on 188 implants placed in 104 patients. BMC Oral Health. 2020 Feb 17;20(1):53. doi: 10.1186/s12903-020-1037-5.

Reference Type DERIVED
PMID: 32066431 (View on PubMed)

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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