Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration

NCT ID: NCT03225495

Last Updated: 2018-01-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-07-01

Brief Summary

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The main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without bone regeneration versus standard diameter implants (4.3 mm) in combination with bone regeneration. To do so, patients with missing upper central incisors, canines, first or second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental implants. Cone beam computed tomographic examination and clinical values will be registered before and after the surgical procedure at 6 and 12 months.

Detailed Description

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Conditions

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Dental Implant Narrow Implant Implant Fracture Guided Bone Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard Implant

Group Type ACTIVE_COMPARATOR

Standard implant

Intervention Type PROCEDURE

Arm - Standard Implant: implant placement in combination with guided bone regeneration;

Ultra-narrow Implant

Group Type EXPERIMENTAL

Ultra-narrow implant

Intervention Type PROCEDURE

Arm - Ultra-narrow implant: implant placement without guided bone regeneration

Interventions

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Standard implant

Arm - Standard Implant: implant placement in combination with guided bone regeneration;

Intervention Type PROCEDURE

Ultra-narrow implant

Arm - Ultra-narrow implant: implant placement without guided bone regeneration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* One missing teeth in position: upper central incisor, canine or premolar
* alveolar ridge thickness of 6 - 8 mm
* alveolar ridge height of ≥ 10 mm

Exclusion Criteria

* Missing data
* ASA ≥ III
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Adin Implants

UNKNOWN

Sponsor Role collaborator

Geistlich Pharma AG

INDUSTRY

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Rui Figueiredo

PhD - Assitant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Odontològic - Universitat de Barcelona

L'Hospitalet de Llobregat, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rui Figueiredo, PhD

Role: CONTACT

00 34 93 402 42 74

Facility Contacts

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Rui Figueiredo, Phd

Role: primary

00 34 93 402 42 74

Other Identifiers

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39/2016

Identifier Type: -

Identifier Source: org_study_id

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