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

July 14, 2019 updated by: Alpha - Bio Tec Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Antofagasta, Chile
        • University of Antofagasta
      • Santiago, Chile
        • Andrés Bello National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone loss
Time Frame: 2 years
bone loss level as will be measured from the radio-graphic images
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative implant survival
Time Frame: 2 years
Counting number of survived implants at the end of the study
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpha - Bio Tec Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ABT-ME-130815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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