Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dental Implant Failed
- Sponsor
- Osstem AIC
- Enrollment
- 100
- Locations
- 10
- Primary Endpoint
- Implant failure
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
Detailed Description
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
Investigators
Marco Tallarico
Coordinator
Osstem AIC
Eligibility Criteria
Inclusion Criteria
- •Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Exclusion Criteria
- •Patients unable to commit to 5 years follow-up.
- •General contraindications to implant surgery.
- •Less then 4 mm of keratinised gingiva crestally (at the implant sites).
- •Immune-suppressed/compromised patients.
- •Patients irradiated in the head and/or neck.
- •Uncontrolled diabetes.
- •Pregnancy or lactation.
- •Untreated periodontal disease.
- •Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
- •Addiction to alcohol or drugs.
Outcomes
Primary Outcomes
Implant failure
Time Frame: From implant placement up to 60 months after loading
Implant removal for any reason will be considered an implant failure.
Crown failure
Time Frame: From crown delivery up to 60 months
Crown replacement for any reason will be considered a crown failure.
Complications
Time Frame: From implant placement up to 60 months after loading
Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.
Secondary Outcomes
- Peri-implant marginal bone level (MBL) changes(From implant placement up to 60 months after loading)
- Probing pocket depth (PPD)(From crown delivery up to 60 months)
- Bleeding on probing (BOP)(From crown delivery up to 60 months)
- plaque index (PI)(From implant placement up to 60 months after loading)
- Implant stability quotient(The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.)
- Pink Esthetic Score(From crown delivery up to 60 months)