Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

Not Applicable

• Conditions: Atrophy of Edentulous Alveolar Ridge
• Interventions: Device: Control; Device: Sloped

• Registration Number: NCT03543618
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2017-10
• Study Start: 2018-03-15
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Study First Posted: 2018-06-01
• Last Update Posted: 2018-06-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Installation of conventional design dental implant
Sloped	Sloped	Installation of sloped design dental implant

Primary Outcome Measures

Name	Time	Method
Clinical assessment of the status of osseointegration	up to 3 years	radiographic bone level, bone consolidation index (ISQ)

Secondary Outcome Measures

Name	Time	Method
The peri-implant health	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)
The health status of adjacent teeth	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)
Biomarkers in the gingival crevicular fluid of adjacent teeth	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
Biomarkers in the gingival crevicular fluid of dental implant	1 year, 2 years, 3 years	Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan