Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

NCT ID: NCT03543618

Last Updated: 2018-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrophy of Edentulous Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Installation of conventional design dental implant

Group Type SHAM_COMPARATOR

Control

Intervention Type DEVICE

Placement of implant with conventional design

Sloped

Installation of sloped design dental implant

Group Type ACTIVE_COMPARATOR

Sloped

Intervention Type DEVICE

Placement of implant with sloped design

Interventions

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Sloped

Placement of implant with sloped design

Intervention Type DEVICE

Control

Placement of implant with conventional design

Intervention Type DEVICE

Other Intervention Names

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"Astra" OsseoSpeedTM Profile EV "Astra" OsseoSpeedTM EV

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Po-Chun Chang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Po-Chun Chang

Role: CONTACT

02-23123456 ext. 67709

Olivia Hsieh

Role: CONTACT

02-23123456 ext. 67704

Facility Contacts

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Po-Chun Chang

Role: primary

02-23123456 ext. 67709

Other Identifiers

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201704081DIPC

Identifier Type: -

Identifier Source: org_study_id

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