NCT02897193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

June 1, 2019

Enrollment Period

3.1 years

First QC Date

September 1, 2016

Last Update Submit

July 14, 2019

Conditions

Upper Central Incisor Edentulism

Outcome Measures

Primary Outcomes (1)

  • bone loss

    bone loss level as will be measured from the radio-graphic images

    2 years

Secondary Outcomes (1)

  • Cumulative implant survival

    2 years

Study Arms (2)

Dental implant with bone augmentation

ACTIVE COMPARATOR

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 mmDevice: Alpha Bio's Graft Bovine boneDevice: Alpha Bio's Graft resorbable membrane

narrow implant

EXPERIMENTAL

patients will be installed with NICE Dental implant 3.2 mm diameter

Device: NICE dental implant 3.2 mm

Interventions

ICE dental implant 4.2 mmDEVICE

ICE dental implant 4.2 mm diameter

Dental implant with bone augmentation
NICE dental implant 3.2 mmDEVICE

NICE dental implant 4.2 mm diameter

narrow implant
Alpha Bio's Graft Bovine boneDEVICE

Alpha Bio's Graft Bovine Bone

Dental implant with bone augmentation
Alpha Bio's Graft resorbable membraneDEVICE

Alpha Bio's Graft resorbable collagen membrane

Dental implant with bone augmentation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Antofagasta

Antofagasta, Chile

Location

Andrés Bello National University

Santiago, Chile

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 13, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-06

Locations

CL(2)