Partially Edentulous Maxilla, Mandible Clinical Trial
Official title:
Submerged vs. Nonsubmerged Single Laser-microgrooved Implants. Clinical and Radiographic Results at 3-years of RCT With Split Mouth Design.
| Verified date | September 2018 |
| Source | University of Roma La Sapienza |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Aim: to evaluate and compare radiographic marginal bone loss (MBL) and soft tissue parameters around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body design and surface, same thread design and distance, and same collar surface (laser-microgrooved), after 3 years of loading.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | September 14, 2018 |
| Est. primary completion date | September 14, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Inclusion criteria were: age = 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. Each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla. Exclusion Criteria: - Exclusion criteria were: implants placed into regenerated bone, lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) =25%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Universita la Sapienza | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| University of Roma La Sapienza |
Italy,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | radiographic marginal bone loss | 3 years |