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Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

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ClinicalTrials.gov Identifier: NCT03543618
Recruitment Status : Unknown
Verified October 2017 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrophy of Edentulous Alveolar Ridge Device: Sloped Device: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Control
Installation of conventional design dental implant
 Device: Control
Placement of implant with conventional design
Other Name: "Astra" OsseoSpeedTM EV
Active Comparator: Sloped
Installation of sloped design dental implant
 Device: Sloped
Placement of implant with sloped design
Other Name: "Astra" OsseoSpeedTM Profile EV


Outcome Measures
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Primary Outcome Measures :
  1. Clinical assessment of the status of osseointegration [ Time Frame: up to 3 years ]
    radiographic bone level, bone consolidation index (ISQ)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543618


Contacts
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Contact: Po-Chun Chang 02-23123456 ext 67709 changpc@ntu.edu.tw
Contact: Olivia Hsieh 02-23123456 ext 67704 ling202643@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Po-Chun Chang    02-23123456 ext 67709    changpc@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Po-Chun Chang National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03543618    
Other Study ID Numbers: 201704081DIPC
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
dental implant
edentulous ridge
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases