Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

Atrophy of Edentulous Alveolar Ridge Clinical Trial

Official title:

Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543618
• Other study ID #: 201704081DIPC
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2017
• Source: National Taiwan University Hospital
• Contact: Po-Chun Chang
• Phone: 02-23123456
• Email: changpc[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Device:
• Sloped
Placement of implant with sloped design
• Control
Placement of implant with conventional design

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment of the status of osseointegration	radiographic bone level, bone consolidation index (ISQ)	up to 3 years
Secondary	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)	0 day, 6 months, 1 year, 2 years, 3 years
Secondary	The peri-implant health	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
Secondary	Biomarkers in the gingival crevicular fluid of adjacent teeth	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
Secondary	Biomarkers in the gingival crevicular fluid of dental implant	Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10	1 year, 2 years, 3 years