Jaw, Edentulous, Partially
Conditions
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.
Interventions
DEVICEOsseoSpeed™
OsseoSpeed™ implant
DEVICENobelSpeedy™ Replace®
NobelSpeedy™ Replace® implant
DEVICENanoTite™ Certain® PREVAIL®
NanoTite™ Certain® PREVAIL® implant
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. | 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
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Alterations | Evaluated at time of implant installation and at the 5-year follow-up visit. | Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement. |
| 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. | Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
| 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. | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group-A. OsseoSpeed™ Implant Subjects that had OsseoSpeed™ implants installed. | 48 |
| Group-B. NobelSpeedy™ Replace® Implant Subjects that had NobelSpeedy™ Replace® implants installed | 49 |
| Group-C. NanoTite™ Certain® PREVAIL® Implant Subjects that had NanoTite™ Certain® PREVAIL® implants installed | 44 |
| Total | 141 |
Baseline characteristics
| Characteristic | Group-A. OsseoSpeed™ Implant | Group-B. NobelSpeedy™ Replace® Implant | Group-C. NanoTite™ Certain® PREVAIL® Implant | Total |
|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 15 | 46 years STANDARD_DEVIATION 17 | 46 years STANDARD_DEVIATION 16 | 45 years STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 42 Participants | 46 Participants | 36 Participants | 124 Participants |
| Region of Enrollment Canada | 10 participants | 9 participants | 7 participants | 26 participants |
| Region of Enrollment United States | 38 participants | 40 participants | 37 participants | 115 participants |
| Sex: Female, Male Female | 23 Participants | 35 Participants | 22 Participants | 80 Participants |
| Sex: Female, Male Male | 25 Participants | 14 Participants | 22 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 48 | 23 / 49 | 10 / 44 |
| serious Total, serious adverse events | 8 / 48 | 3 / 49 | 8 / 44 |
Outcome results
Primary
Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
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.
Time frame: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Population: A total of 88 subjects completed the 5-year follow-up visit. Five radiographs (two in group A, two in group B and one in group C) were not possible to evaluate, giving an overall number of 83 subjects (83 implants) as basis for the analysis of Gingival Zenith score change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-A. OsseoSpeed™ Implant | Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. | 0.08 Millimeter | Standard Deviation 0.65 |
| Group-B. NobelSpeedy™ Replace® Implant | Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. | -0.10 Millimeter | Standard Deviation 1 |
| Group-C. NanoTite™ Certain® PREVAIL® Implant | Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. | 0.00 Millimeter | Standard Deviation 0.58 |
Secondary
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.
Time frame: Measured at the implant loading and at the 5-year follow-up after loading.
Population: A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the assessment of BoP change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-A. OsseoSpeed™ Implant | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. | 0.13 Change in proportion of surfaces | Standard Deviation 0.38 |
| Group-B. NobelSpeedy™ Replace® Implant | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. | 0.04 Change in proportion of surfaces | Standard Deviation 0.34 |
| Group-C. NanoTite™ Certain® PREVAIL® Implant | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. | 0.07 Change in proportion of surfaces | Standard Deviation 0.33 |
Secondary
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Time frame: Measured at time of loading of permanent restoration and at the 5-year follow-up.
Population: A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the PPD assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-A. OsseoSpeed™ Implant | Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | 0.08 Millimeter | Standard Deviation 0.88 |
| Group-B. NobelSpeedy™ Replace® Implant | Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | -0.06 Millimeter | Standard Deviation 0.88 |
| Group-C. NanoTite™ Certain® PREVAIL® Implant | Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | -0.09 Millimeter | Standard Deviation 0.57 |
Secondary
Marginal Bone Level Alterations
Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement.
Time frame: Evaluated at time of implant installation and at the 5-year follow-up visit.
Population: A total of 88 subjects completed the 5-year follow-up visit. Three radiographs (all in group C) were not possible to evaluate, giving an overall number of 85 subjects (85 implants) as basis for the analysis of marginal bone level change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-A. OsseoSpeed™ Implant | Marginal Bone Level Alterations | -0.16 Millimeter | Standard Deviation 0.45 |
| Group-B. NobelSpeedy™ Replace® Implant | Marginal Bone Level Alterations | -0.92 Millimeter | Standard Deviation 0.7 |
| Group-C. NanoTite™ Certain® PREVAIL® Implant | Marginal Bone Level Alterations | -0.81 Millimeter | Standard Deviation 1.06 |