Back to resultsEvaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Primary Purpose
Atrophy of Edentulous Alveolar Ridge
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sloped
Control
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy of Edentulous Alveolar Ridge focused on measuring dental implant, edentulous ridge
Eligibility 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control
Sloped
Arm Description
Installation of conventional design dental implant
Installation of sloped design dental implant
Outcomes
Primary Outcome Measures
Clinical assessment of the status of osseointegration
radiographic bone level, bone consolidation index (ISQ)
Secondary Outcome Measures
The health status of adjacent teeth
radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)
The peri-implant health
radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)
Biomarkers in the gingival crevicular fluid of adjacent teeth
Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10
Biomarkers in the gingival crevicular fluid of dental implant
Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10
Full Information
NCT ID
NCT03543618
First Posted
March 20, 2018
Last Updated
May 31, 2018
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03543618
Brief Title
Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Official Title
Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Edentulous Alveolar Ridge
Keywords
dental implant, edentulous ridge
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Installation of conventional design dental implant
Arm Title
Sloped
Arm Type
Active Comparator
Arm Description
Installation of sloped design dental implant
Intervention Type
Device
Intervention Name(s)
Sloped
Other Intervention Name(s)
"Astra" OsseoSpeedTM Profile EV
Intervention Description
Placement of implant with sloped design
Intervention Type
Device
Intervention Name(s)
Control
Other Intervention Name(s)
"Astra" OsseoSpeedTM EV
Intervention Description
Placement of implant with conventional design
Primary Outcome Measure Information:
Title
Clinical assessment of the status of osseointegration
Description
radiographic bone level, bone consolidation index (ISQ)
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
The health status of adjacent teeth
Description
radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)
Time Frame
0 day, 6 months, 1 year, 2 years, 3 years
Title
The peri-implant health
Description
radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)
Time Frame
1 year, 2 years, 3 years
Title
Biomarkers in the gingival crevicular fluid of adjacent teeth
Description
Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10
Time Frame
0 day, 6 months, 1 year, 2 years, 3 years
Title
Biomarkers in the gingival crevicular fluid of dental implant
Description
Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10
Time Frame
1 year, 2 years, 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Chun Chang
Phone
02-23123456
Ext
67709
Email
changpc@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Hsieh
Phone
02-23123456
Ext
67704
Email
ling202643@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Chun Chang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Chun Chang
Phone
02-23123456
Ext
67709
Email
changpc@ntu.edu.tw
12. IPD Sharing Statement
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Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
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