Randomized Clinical Trial to Validate Use of Implants and Abutments With Biologically Oriented Preparation Technique (I.B.O.P.T.)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Marginal bone level
Study Overview
Brief Summary
This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female ≥18 years old.
- •Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge);
- •Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm.
- •Healthy ASA type I and II patients.
- •Full-mouth plaque index <20.
Exclusion Criteria
- •Smokers ≥10 cigarettes/day.
- •Presence of implant-supported restorations adjacent to the study site.
- •Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP).
- •Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).
- •Uncontrolled diabetes.
- •Severe bruxism.
- •Pregnancy.
- •Previous history of radiotherapy.
Outcomes
Primary Outcomes
Marginal bone level
Time Frame: Baseline to 12-months follow-up
Changes in interproximal marginal bone level with standardization of the radiograph
Soft tissue volumetric analysis
Time Frame: Baseline to 12-motnhs follow-up
Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit
Secondary Outcomes
No secondary outcomes reported