NCT03225495

Brief Summary

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.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

July 18, 2017

Last Update Submit

January 15, 2018

Conditions

Dental ImplantNarrow ImplantImplant FractureGuided Bone Regeneration

Outcome Measures

Primary Outcomes (1)

  • Success

    According to criteria described by Albrektsson et al. 1986

    12 months

Study Arms (2)

Standard Implant

ACTIVE COMPARATOR
Procedure: Standard implant

Ultra-narrow Implant

EXPERIMENTAL
Procedure: Ultra-narrow implant

Interventions

Standard implantPROCEDURE

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

Standard Implant
Ultra-narrow implantPROCEDURE

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

Ultra-narrow Implant

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Missing data
  • ASA ≥ III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontològic - Universitat de Barcelona

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Central Study Contacts

Rui Figueiredo, PhD

CONTACT

00 34 93 402 42 74ruipbfigueiredo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD - Assitant Professor

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

ES(1)