Marginal Bone Levels Around Implants With Definitive Abutments Of One and Three Millimeters: A One Year Of Follow Up Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 69
- Locations
- 2
- Primary Endpoint
- Mucosal thickness (MT)
Study Overview
Brief Summary
The aim of the present study was to evaluate the peri-implant crestal bone level around implants placed 1.5 mm subcrestally, with a 1 mm or 3 mm definitive abutment height at the time of implant placement after 1 year. Patients were selected from the Department of Periodontology at Universitat Internacional de Catalunya. X-rays were taken at the time of implant placement, 8-12 weeks after placement, after screwing the provisional rehabilitation and at 12 months. An examiner indicated the crestal marginal bone level, the marginal bone level of the implant, and the marginal bone level of the abutment . The examiner, independent to the study, carried out the radiographic analysis using the Image J software on periapical radiographs.
Detailed Description
The aim of the present study was to evaluate the peri-implant crestal bone level around implants placed 1.5 mm subcrestally with PS and a 1 mm or 3 mm definitive AH at the time of implant placement after 1 year.
- Study design
This randomized controlled prospective study was carried out after its acceptance by the Clinical Research Ethics Committee with code number PER-ECL-2015-05, at the Faculty of Dentistry of the Universitat Internacional de Catalunya (UIC-Barcelona). 2. Study population and selection criteria
Patients were selected from the Department of Periodontology at Universitat Internacional de Catalunya. Once signed the informed consent, patients were screened following inclusion criteria. 3. Randomization
The randomization between the groups (Group A/Group B) was performed using OxMaR system (Oxford Minimization and Randomization) to determine the use of a 1 mm (Group A) or 3 mm (Group B) height abutments. The surgeon was unaware of the abutment height until after the insertion of the implant. 4. Surgical and prosthetic treatment protocol Dental implants were placed by second and third year students of the Postgraduate Program in Periodontology at UIC-Barcelona, supervised by two experienced professors (MM, MA). Vega® implant, Klockner, several lengths (8, 10, 12 mm) and diameters (3.5, 4.0, 4.5 mm) were used depending on bone availability. The rehabilitation was carried out by students of the Postgraduate program of Esthetic and Prosthetic Dentistry at UIC-Barcelona, using the permanent prosthetic abutments with two different heights (1 or 3 mm) placed the day of surgery. The screwed-retained rehabilitations to the Permanent® abutment were single crowns or partial restorations (maximum of 3 crowns), both performed with CAD-CAM technology. Temporary restorations were placed between 2 to 4 months after surgery, for 4 weeks, before the placement of the definitive ones.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The surgeon was unaware of the abutment height until after the insertion of the implant. Patients were unknown the abutment group. The examiner, independent to the study, carried out the radiographic analysis.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female ≥18 years old;
- •Controlled ASA1 or ASA2 patient;
- •Healthy periodontium or with controlled periodontal disease;
- •Need for rehabilitation with implants in partially posterior edentulous sextants;
- •Full Mouth Plaque Score (FMPS) less than 20% at the time of surgery;
- •Collaborating patients.
- •According to the implant location:
- •Healed posterior sites, with a minimum of 2 months post-extraction;
- •Ridge width of 7 mm or more and of 10 mm of height to the mandibular nerve and 8 mm to the maxillary sinus;
- •Minimum keratinized mucosa (KM) width of 4 mm;
- •Antagonist dentition having a fixed restoration or natural teeth, (5) restorative space greater than 5 mm.
Exclusion Criteria
- •Patients with endocrine, immunological or metabolic alterations;
- •Pregnancy, allergy to any metallic component of the implant;
- •Drug consumption or alcoholism;
- •Tobacco ≥10 cig/d and
- •Severe bruxism and TMJ pathology.
- •According to the implant location:
- •Require regeneration techniques;
- •Width of KM less than 2 mm at any implant site;
- •Infections in the treatment area;
- •Absence of implant primary stability and
- •Being unable to perform prosthetically guided screw-retained restorations.
Outcomes
Primary Outcomes
Mucosal thickness (MT)
Time Frame: baseline
Mucosal thickness (MT) before placement of the implant using a PCP-UNC15 periodontal probe. This measure will be compared with the abutment high and bone loss at 1 year.
Change from Baseline Bone Loss, at 8-12 weeks and 1 year.
Time Frame: baseline, 8-12 weeks and 1 year
X-rays were taken at the time of implant placement, 8-12 weeks after placement, after screwing the provisional rehabilitation and at 12 months.
Secondary Outcomes
- Bleeding on probing at 1 year(1 year)
- Plaque index at 1 year(1 year)
- Probing depth at 1 year(1 year)
- Change from Baseline the resonance frequency analysis at 8-12 weeks and 1 year.(baseline, 8-12 weeks and 1 year)
Investigators
Jose Nart Molina
Chairman and Program Director, Department of Periodontology at UIC Barcelona
Universitat Internacional de Catalunya