NCT03543618

Brief Summary

The aim of this study was to investigate the therapeutic effect of sloped dental implants. It can reduce the need of osteoectomy, reduce discomfort of procedures, and is easier for maintenance.

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 Mar 2018

Longer than P75 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

March 15, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

June 1, 2018

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

March 20, 2018

Last Update Submit

May 31, 2018

Conditions

Atrophy of Edentulous Alveolar Ridge

Keywords

dental implantedentulous ridge

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment of the status of osseointegration

    radiographic bone level, bone consolidation index (ISQ)

    up to 3 years

Secondary Outcomes (4)

  • The health status of adjacent teeth

    0 day, 6 months, 1 year, 2 years, 3 years

  • The peri-implant health

    1 year, 2 years, 3 years

  • Biomarkers in the gingival crevicular fluid of adjacent teeth

    0 day, 6 months, 1 year, 2 years, 3 years

  • Biomarkers in the gingival crevicular fluid of dental implant

    1 year, 2 years, 3 years

Study Arms (2)

Control

SHAM COMPARATOR

Installation of conventional design dental implant

Device: Control

Sloped

ACTIVE COMPARATOR

Installation of sloped design dental implant

Device: Sloped

Interventions

SlopedDEVICE

Placement of implant with sloped design

Also known as: "Astra" OsseoSpeedTM Profile EV
Sloped
ControlDEVICE

Placement of implant with conventional design

Also known as: "Astra" OsseoSpeedTM EV
Control

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
20-80 years old with appropriate oral cleaning ability; the computer tomography shows \> 1 mm buccolingual discrepancy of alveolar ridge height; no generalized periodontitis, or had history of periodontitis but has been completed treatment; no major systemic infection or major systemic illness; not taken antibiotics in the past two weeks Not pregnant or breastfeeding

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Po-Chun Chang

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Chun Chang

CONTACT

02-23123456changpc@ntu.edu.tw

Olivia Hsieh

CONTACT

02-23123456ling202643@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

June 1, 2018

Study Start

March 15, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

June 1, 2018

Record last verified: 2017-10

Locations

TW(1)