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Trial record 1 of 1 for:    ABT-ME-130815
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Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .

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ClinicalTrials.gov Identifier: NCT02897193
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alpha - Bio Tec Ltd.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Upper Central Incisor Edentulism Device: ICE dental implant 4.2 mm Device: NICE dental implant 3.2 mm Device: Alpha Bio's Graft Bovine bone Device: Alpha Bio's Graft resorbable membrane Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Device: ICE dental implant 4.2 mm
ICE dental implant 4.2 mm diameter

Device: Alpha Bio's Graft Bovine bone
Alpha Bio's Graft Bovine Bone

Device: Alpha Bio's Graft resorbable membrane
Alpha Bio's Graft resorbable collagen membrane
Experimental: narrow implant
patients will be installed with NICE Dental implant 3.2 mm diameter
 Device: NICE dental implant 3.2 mm
NICE dental implant 4.2 mm diameter


Outcome Measures
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Primary Outcome Measures :
  1. bone loss [ Time Frame: 2 years ]
    bone loss level as will be measured from the radio-graphic images


Secondary Outcome Measures :
  1. Cumulative implant survival [ Time Frame: 2 years ]
    Counting number of survived implants at the end of the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897193


Locations
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Chile
University of Antofagasta
Antofagasta, Chile
Andrés Bello National University
Santiago, Chile
Sponsors and Collaborators
Alpha - Bio Tec Ltd.
More Information
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Additional Information:
sponsor site  This link exits the ClinicalTrials.gov site

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Responsible Party: Alpha - Bio Tec Ltd.
ClinicalTrials.gov Identifier: NCT02897193     History of Changes
Other Study ID Numbers: ABT-ME-130815
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: June 2019