Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

May 31, 2018 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

20 OsseoSpeed ™ Profile EV and 20 OsseoSpeed ™ EV groups will be randomly implanted into the oblique edentulous ridges of subjects, and the treatment response will be monitored for 3 years. The implantation area will be randomly divided into two groups, One group was treated with OsseoSpeed ™ Profile EV (sloped group) and the other group was treated with OsseoSpeed ™ EV (control group). The same patient had the same implant as the same quadrant.

The patient will be followed up regularly for follow-up, followed by clinical attachment level, probing depth, bleeding on probing, keratinized gingival width (Keratinized gingiva), mobility (mobility) and other clinical indicators of the measurement, regular dental radiography, gingival crevicular fluid (GCF) collection and bone integration measurement.

After six months of implantation, prosthesis will delivered and loaded functionally, and regular follow-up will be arranged. In each time of follow-up, examination will be carried out with regards to periodontal pocket depth, clinical attachment height, periodontal bleeding index, keratinized gingival width, and other clinical indicators of the measurement, at the end of the experiment, that is, after three years, and then a dental root film irradiation, GCF collection and osseointegration measurement.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Installation of conventional design dental implant
Device: Control
Placement of implant with conventional design
Other Names:
  • "Astra" OsseoSpeedTM EV
Active Comparator: Sloped
Installation of sloped design dental implant
Device: Sloped
Placement of implant with sloped design
Other Names:
  • "Astra" OsseoSpeedTM Profile EV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment of the status of osseointegration
Time Frame: up to 3 years
radiographic bone level, bone consolidation index (ISQ)
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The health status of adjacent teeth
Time Frame: 0 day, 6 months, 1 year, 2 years, 3 years
radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)
0 day, 6 months, 1 year, 2 years, 3 years
The peri-implant health
Time Frame: 1 year, 2 years, 3 years
radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)
1 year, 2 years, 3 years
Biomarkers in the gingival crevicular fluid of adjacent teeth
Time Frame: 0 day, 6 months, 1 year, 2 years, 3 years
Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10
0 day, 6 months, 1 year, 2 years, 3 years
Biomarkers in the gingival crevicular fluid of dental implant
Time Frame: 1 year, 2 years, 3 years
Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10
1 year, 2 years, 3 years

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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 (Actual)

March 15, 2018

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201704081DIPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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