Evaluation of Straumann Bone Level Tapered® Implants Using Screwed Abutment Height in Partially Edentulous Patients: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Marginal Bone Loss
Study Overview
Brief Summary
A prospective randomized controlled clinical trial will be conducted. Study groups will be assigned as described above. The patients will be randomly divided into two groups in order to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant System, Institut Straumann AG, Basel, Switzerland).
Detailed Description
48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).
Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.
Study groups
Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)
Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed informed consent
- •Overall, healthy subjects
- •Females and males of at least eighteen-years
- •Requiring a minimum of two implants (molar and/or premolar teeth)
- •Adequate oral hygiene (less than 15% FMPS)
- •Able to follow instructions and attend a regular compliance
- •Enough bone to place a standard implant of 4.1 mm diameter.
Exclusion Criteria
- •Acute local infection
- •Occlusal overload with parafunctional activity (assessed clinically)
- •Large occlusal discrepancies
- •Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
- •Smokers (more than 10 cigarettes/day)
- •Drug and/or alcoholic dependencies
- •Medical conditions contraindicating implant surgery
- •History of head and/or neck radiation
- •Bisphosphonate therapy
Arms & Interventions
Control group
Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery)
Intervention: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group) (Device)
Test group
Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT
Intervention: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group) (Device)
Outcomes
Primary Outcomes
Marginal Bone Loss
Time Frame: After implant loading (baseline)and once every year to 24 months follow-up
Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.
Secondary Outcomes
- Probing Depth(After implant loading (baseline)and once every year to 36 months follow-up)
- Bleeding on Probing(After implant loading (baseline)and once every year to 36 months follow-up)
- Keratinized Mucosa Width(After implant loading (baseline)and once every year to 36 months follow-up)
Investigators
Jordi Gargallo-Albiol
Associate Professor of Oral and Maxillofacial Surgery
Universitat Internacional de Catalunya