Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 141
- Locations
- 4
- Primary Endpoint
- Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
Study Overview
Brief Summary
The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of informed consent
- •At least 18 years
- •In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24
- •The following should be considered at inclusion but can not be fulfilled until at Visit 2:
- •Edentulous for at least 5 months at study site
- •A buccal-lingual bone width at study site of at least 5.5 mm
- •A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
- •A keratinized mid-buccal mucosal height of at least 2 mm at study site
- •Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss
- •Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
- •An opposing dentition with teeth, implants or prosthesis
Exclusion Criteria
- •Insufficient interocclusal distance for implant placement and restoration at study site
- •Tooth adjacent (mesial and/or distal) to study site is ankylosed
- •More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
- •Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
- •Untreated rampant caries and/or uncontrolled periodontal disease
- •Class II division 2 malocclusion (Edward Hartley Angle)
- •Use of tobacco within last 6 months
- •Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
- •Current alcohol or drug abuse
- •Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Use of any substance that will influence bone metabolism
- •Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- •History of radiation in the head and neck region
- •Known pregnancy, pregnancy tests will be performed as per local requirements.
- •Unable or unwilling to return for follow-up visits for a period of 5 years
- •Unlikely to be able to comply with study procedures according to Investigators judgement
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)
- •Previous enrollment or randomization of treatment in the present study.
Arms & Interventions
A
Intervention: OsseoSpeed™ (Device)
B
Intervention: NobelSpeedy™ Replace® (Device)
C
Intervention: NanoTite™ Certain® PREVAIL® (Device)
Outcomes
Primary Outcomes
Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
Time Frame: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.
Secondary Outcomes
- Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD(Measured at time of loading of permanent restoration and at the 5-year follow-up.)
- Marginal Bone Level Alterations(Evaluated at time of implant installation and at the 5-year follow-up visit.)
- Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.(Measured at the implant loading and at the 5-year follow-up after loading.)