Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .

NCT ID: NCT02897193

Last Updated: 2019-07-16

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

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures.

The comparison between these two solutions will be evaluated in the trial.

Detailed Description

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Conditions

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Upper Central Incisor Edentulism

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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Dental implant with bone augmentation

patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation

Group Type ACTIVE_COMPARATOR

ICE dental implant 4.2 mm

Intervention Type DEVICE

ICE dental implant 4.2 mm diameter

Alpha Bio's Graft Bovine bone

Intervention Type DEVICE

Alpha Bio's Graft Bovine Bone

Alpha Bio's Graft resorbable membrane

Intervention Type DEVICE

Alpha Bio's Graft resorbable collagen membrane

narrow implant

patients will be installed with NICE Dental implant 3.2 mm diameter

Group Type EXPERIMENTAL

NICE dental implant 3.2 mm

Intervention Type DEVICE

NICE dental implant 4.2 mm diameter

Interventions

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ICE dental implant 4.2 mm

ICE dental implant 4.2 mm diameter

Intervention Type DEVICE

NICE dental implant 3.2 mm

NICE dental implant 4.2 mm diameter

Intervention Type DEVICE

Alpha Bio's Graft Bovine bone

Alpha Bio's Graft Bovine Bone

Intervention Type DEVICE

Alpha Bio's Graft resorbable membrane

Alpha Bio's Graft resorbable collagen membrane

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Upper central incisor edentulism
* bone width between 3.5-4.5 mm
* requirement of only one implant supported crown
* patient is willing to sign an informed consent

Exclusion Criteria

* General contraindications to implant surgery.
* Immunosuppressed or immunocompromised patients
* Patients irradiated in the head and neck area.
* Patients with poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnancy or lactation.
* Addiction to alcohol or drugs.
* Untreated periodontal disease.
* Treated or under treatment with intravenous amino-biphosphonates.
* Poor oral hygiene and motivation.
* Psychiatric problems and/or unrealistic expectations.
* Acute infection (abscess) or suppuration in the area intended for implant placement.
* Patients referred only for implant placement if cannot be followed at the treatment centre.
* Patient unable to attend the follow-up controls for 3 years after implant loading.
* Patient included in other studies, if this protocol cannot be properly followed.
* Immediate post-extractive sites (to be eligible at least 3 months must have passed since extraction).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alpha - Bio Tec Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Antofagasta

Antofagasta, , Chile

Site Status

Andrés Bello National University

Santiago, , Chile

Site Status

Countries

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Chile

Related Links

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Other Identifiers

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ABT-ME-130815

Identifier Type: -

Identifier Source: org_study_id

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