Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implant
- Sponsor
- University of Valencia
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Peri-implant bone level changes
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
David Peñarrocha Oltra
Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)
University of Valencia
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Peri-implant bone level changes
Time Frame: 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 Outcomes
- Probing pocket depth(12 months after implant loading)
- Bleeding on probing(12 months after implant loading)
- Peri-implant soft tissue recession(12 months after implant loading)
- Implant survival rate(12 months after implant loading)