Bone Resorption, Dental Implant
Conditions
Brief summary
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.
Detailed description
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).
Interventions
PROCEDURECommercially available high abutments placement
Patients will be randomly selected for the commercially available high abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, conventional high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.
PROCEDUREModified shape abutments
Patients will be randomly selected for the modified shape abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, modified high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. Final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues. * Bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures. * Patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day)
Exclusion criteria
* Patients unable to commit to follow-up. * General contraindications to implant surgery. * Immuno-suppressed/immune-compromised patients. * Patients irradiated in the head and/or neck. * Uncontrolled diabetes. * Pregnancy or lactation. * Untreated periodontal disease. * Poor oral hygiene and motivation. * Addiction to alcohol or drugs. * Psychiatric problems and/or unrealistic expectations. * Patients with an acute infection (abscess) or suppuration in the site intended for implant placement. * Patients treated or under treatment with intravenous amino-bisphosphonates. * Patients referred only for implant placement if the follow-up cannot be done at the treatment center. * Patients participating in other studies, if the present protocol could not be fully adhered to.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant bone level changes | 12 months after implant loading | Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival rate | 12 months after implant loading | % of implants in function |
| Probing pocket depth | 12 months after implant loading | Measured in millimeters with a millimetered periodontal probe |
| Bleeding on probing | 12 months after implant loading | Positive or negative bleeding after having probed with a millimetered periodontal probe |
| Peri-implant soft tissue recession | 12 months after implant loading | Measured in millimeters with a millimetered periodontal probe |
Countries
Spain
Outcome results
None listed