Jaw, Edentulous, Partially
Conditions
Keywords
Dental Implant
Brief summary
The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement
Detailed description
The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.
Interventions
DEVICEStraumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
Sponsors
Institut Straumann AG
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
* Males and females \>18 years of age. * Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45). * Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions * Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations. * Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length. * Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing according to the protocol * Signed informed consent document before being treated in the study
Exclusion criteria
* Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes) * Any contraindications for oral surgical procedures * Current untreated periodontitis or gingivitis * Probing pocket depth of more than 4 mm at one of the adjacent teeth * Mucosal diseases (e.g. erosive lichen planus) * History of local irradiation therapy * Bone augmentation procedures if the procedure require healing time of more than 12 weeks after implant placement * Implants in adjacent position to planned implant * Severe bruxing or clenching habits * Heavy smokers: Patients who smoke more than 20 cigarettes per day * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation. * Patients with inadequate oral hygiene or unmotivated for adequate home care Secondary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) | Baseline and 6 months | The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | 6 months | The percentage of implants that remain in place in the jaw. |
Countries
Australia, Germany, Italy, Spain, Sweden, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Submerged Healing The dental implants will be placed using a submerged healing treatment | 73 |
| Trans-mucosal Healing The dental implants will be placed using a trans-mucosal healing treatment | 72 |
| Total | 145 |
Baseline characteristics
| Characteristic | Submerged Healing | Trans-mucosal Healing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 13 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 59 Participants | 121 Participants |
| Region of Enrollment Australia | 10 participants | 9 participants | 19 participants |
| Region of Enrollment Germany | 18 participants | 14 participants | 32 participants |
| Region of Enrollment Italy | 6 participants | 6 participants | 12 participants |
| Region of Enrollment Spain | 12 participants | 12 participants | 24 participants |
| Region of Enrollment Sweden | 6 participants | 5 participants | 11 participants |
| Region of Enrollment Switzerland | 7 participants | 7 participants | 14 participants |
| Region of Enrollment United States | 14 participants | 19 participants | 33 participants |
| Sex: Female, Male Female | 39 Participants | 31 Participants | 70 Participants |
| Sex: Female, Male Male | 34 Participants | 41 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 73 | 10 / 72 |
| serious Total, serious adverse events | 2 / 73 | 0 / 72 |
Outcome results
Primary
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Time frame: Baseline and 6 months
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Submerged Healing | Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) | -0.32 millimeters | Standard Deviation 0.47 |
| Trans-mucosal Healing | Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) | -0.29 millimeters | Standard Deviation 0.35 |
Secondary
Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Submerged Healing | Implant Survival Rate | 100 % of implants |
| Trans-mucosal Healing | Implant Survival Rate | 98.3 % of implants |
Secondary
Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Submerged Healing | Implant Survival Rate | 100 % of implants |
| Trans-mucosal Healing | Implant Survival Rate | 98.3 % of implants |