The Role of Immediate Provisional Restorations on Bone Level Implants. A Randomised, Single Blind Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Jaw, Edentulous, Partially
- Sponsor
- Institut Straumann AG
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and immediately provisionalised versus the same type of implants placed in healed alveolar ridge but not provisionalised. In both cases the implants will be loaded at 16 weeks (final restorations). The outcomes will be evaluated over a 2-year period.
Detailed Description
This is a prospective, randomised, controlled, single blind, and single center study. The total study duration for each patient should be 24 months. Straumann Bone Level Ø 4.1 mm SLActive implants will be placed for single tooth replacement, followed by either immediate provisional prosthetic loading or no provisionalised. The final prosthetic loading is made at 16 weeks after implant loading. The implant length will be selected according to the clinical indication of the site based on previous radiographic evaluation. In total 11 visits per patient are scheduled in this study. Bone level changes, implant success and survival rate, soft tissue changes, aesthetic outcome and adverse events (AEs) will be assessed. The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products. One center in the United Kingdom will participate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General inclusion criteria
- •Males and females, age 18 to 75 years of age (the subjects should be legally able to give informed consent to the procedure; age limitation is also present to avoid inclusion of subjects with incomplete cranio-facial growth).
- •Absence of relevant medical conditions. Patients with contributing medical history in which any elective oral surgical intervention would be contraindicated should be excluded. In particular patients with uncontrolled or poorly controlled diabetes, or unstable or life threatening conditions should be excluded.
- •Absence of uncontrolled or untreated periodontal disease.
- •Absence of untreated caries lesions.
- •Patient in good medical and psychological health as documented by self assessment
- •Patient's availability for follow-up according to the protocol.
- •Local inclusion criteria
- •A single tooth replacement is required in the incisor, canine, pre-molar and first molar region. Multiple-implant restorations (non adjacent to the test implant) can be performed during the study (not to be included as test implants).
- •at least 8 weeks post extraction where the soft tissues of the socket have healed
Exclusion Criteria
- •General exclusion criteria
- •Patients who have any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation.
- •Female patients who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
- •Patients who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists, cyclosporine) within one month of baseline visit.
- •Patients who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily aspirin of more than 81 mg.
- •Patients who knowingly have HIV or Hepatitis.
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
- •Patients who have undergone administration of any investigational drug within 30 days of study initiation.
- •Alcoholism or chronically drug abuse causing systemic compromisation.
- •Patients who are heavy smokers (\>10/cigarettes per day).
Outcomes
Primary Outcomes
Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment
Time Frame: between baseline and one year post treatment
The primary parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements at baseline and one year after implant placement. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants, on digitized standardized peri-apical x-rays using an image analysis computer program.
Secondary Outcomes
- No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months(2 years after implant placement)
- Number of Participants With Survival Rate of the Implants at 12 and 24 Months(1 year and 2 years after implant placement)
- Probing Pocket Depth(Recorded at 16 weeks, 6, 12, and 24 months after implant placement)
- Gingival Recessions (REC)(Recorded at 16 weeks, 6, 12 and 24 months after implant placement)
- Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index(Recorded at 12 and 24 months after implant placement)
- Adverse Events(From randomization to 2 years after implant placement)
- Soft Tissue Changes, Pink Aesthetic Score(Recorded at 12 and 24 months after implant placement)