Partial Edentulism
Conditions
Keywords
Dental implants
Brief summary
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
Detailed description
This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.
Interventions
DEVICESLActive dental implant
Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery. Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery. In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.
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 must be at least 18 years of age * Have at least one missing tooth in positions FDI 4, 5, 6, or 7 in any quadrant (ADA positions 2, 3, 4, 5; or 12, 13, 14, 15; or 20, 21, 22, 23; or 28, 29, 30, 31.) * Subjects desire an implant supported restoration on1 to 4 implants per quadrant * The tooth/teeth position(s) at the proposed implant site must have been extracted or lost at least 4 months before the date of implantation and be fully healed * Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann standard 4.1 mm diameter implant of at least 8 mm length without the use of concurrent bone augmentation techniques. If more bone is available and is indicated a Straumann standard 4.8 mm diameter implant with a wide neck of at least 8 mm length may be used, i.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of bone lingual and buccal bone will remain * The opposing dentition must be natural teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed * Patients must be committed to the study for its full duration.
Exclusion criteria
* Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) * Medical conditions requiring prolonged use of steroids * History of leukocyte dysfunction and deficiencies * History of bleeding disorders * History of neoplastic disease requiring the use of chemotherapy * History of radiation therapy to the head and neck * Patients with history of renal failure * Patients with severe or uncontrolled metabolic bone disorders * Uncontrolled endocrine disorders * Physical handicaps that would interfere with the ability to perform adequate oral hygiene * Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0 * Alcoholism or drug abuse * Patients infected with HIV * Patients who smoke \>10 cigarettes per day or cigar equivalents, or who chew tobacco * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability * Local inflammation, including untreated periodontitis * Mucosal diseases such as erosive lichen planus * History of local irradiation therapy * Presence of osseous lesions * Unhealed extraction sites (less than 4 months post extraction of teeth in intended sites) * Bone surgery (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement and the site fully healed. Note: Minor bone enhancement using harvested bone from the implant site and a resorbable membrane is allowed at the time of implant placement * Patients requiring bone grafting at the surgical sites at the time of surgery. * Severe bruxing or clenching habits * Persistent intraoral infection * Lack of primary stability of one (or more) implant(s) at surgery. In this instance the patient must be withdrawn and the patient treated accordingly * Patients with inadequate oral hygiene or unmotivated for adequate home care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | 20-23 Weeks post-surgery | Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation |
| Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected | until the 3 year post-surgery | Patients affected by AE Patients affected by related/ unknown AE |
| Implant Success | 20-23 weeks post-surgery | Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant |
| Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | until the 3 year post-surgery | Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs) |
Countries
Austria, Germany, Ireland, Netherlands, Portugal, Spain, Sweden, Switzerland, United States
Participant flow
Pre-assignment details
From the 280 patients (146/134 immediate/early loading group) who received a study implant 266 patients (138/128 immediate/early loading group) fulfilled all primary and secondary inclusion/exclusion criteria after Implantation. The main effectiveness analysis was performed on this population
Participants by arm
| Arm | Count |
|---|---|
| Immediate Loading Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant | 138 |
| Early Loading Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant | 128 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | complications | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | not eligible | 8 | 6 |
| Overall Study | others | 7 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Early Loading | Immediate Loading | Total |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 12.4 | 46.1 years STANDARD_DEVIATION 13.3 | 46.3 years STANDARD_DEVIATION 12.8 |
| implant distribution maxilla, mandible patients with implants in both jaws | 12 participants | 19 participants | 31 participants |
| implant distribution maxilla, mandible patients with implants in the mandible | 79 participants | 72 participants | 151 participants |
| implant distribution maxilla, mandible patients with implants in the maxilla | 37 participants | 47 participants | 84 participants |
| Number of implants placed | 186 implants | 197 implants | 383 implants |
| Sex: Female, Male Female | 74 Participants | 74 Participants | 148 Participants |
| Sex: Female, Male Male | 54 Participants | 64 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 146 | 12 / 134 |
| serious Total, serious adverse events | 2 / 146 | 1 / 134 |
Outcome results
Primary
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery
Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.82 mm | Standard Deviation 0.89 |
| Early Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.56 mm | Standard Deviation 0.73 |
Primary
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 1 year post-surgery
Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.90 mm | Standard Deviation 0.9 |
| Early Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.59 mm | Standard Deviation 0.79 |
Primary
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 2 years post-surgery
Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.89 mm | Standard Deviation 0.9 |
| Early Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.57 mm | Standard Deviation 0.83 |
Primary
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 3 years post-surgery
Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.88 mm | Standard Deviation 0.82 |
| Early Loading | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | 0.57 mm | Standard Deviation 0.84 |
Secondary
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 3 years post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Success | 174 implants |
| Early Loading | Implant Success | 164 implants |
Secondary
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 20-23 weeks post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Success | 187 implants |
| Early Loading | Implant Success | 174 implants |
Secondary
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 1 years post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Success | 185 implants |
| Early Loading | Implant Success | 172 implants |
Secondary
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 2 years post-surgery
Population: The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Success | 177 implants |
| Early Loading | Implant Success | 164 implants |
Secondary
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Time frame: 3 years post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Survival | 192 implants |
| Early Loading | Implant Survival | 180 implants |
Secondary
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation
Time frame: 20-23 Weeks post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Survival | 193 implants |
| Early Loading | Implant Survival | 180 implants |
Secondary
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Time frame: 1 year post-surgery
Population: Number of implants placed. Implants from drop-outs are not included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Survival | 193 implants |
| Early Loading | Implant Survival | 180 implants |
Secondary
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Time frame: 2 years post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Loading | Implant Survival | 192 implants |
| Early Loading | Implant Survival | 180 implants |
Secondary
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events
Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)
Time frame: until the 3 year post-surgery
Population: All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of Adverse Events | 56 number of events |
| Immediate Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of related/unknown AEs | 26 number of events |
| Immediate Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of related/unknown SAEs | 0 number of events |
| Immediate Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of Serious Adverse Events | 3 number of events |
| Early Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of Serious Adverse Events | 1 number of events |
| Early Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of Adverse Events | 41 number of events |
| Early Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of related/unknown SAEs | 0 number of events |
| Early Loading | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of related/unknown AEs | 17 number of events |
Secondary
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected
Patients affected by AE Patients affected by related/ unknown AE
Time frame: until the 3 year post-surgery
Population: All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Loading | Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected | Patients affected by AE | 38 patients affected |
| Immediate Loading | Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected | Patients affected by related/ unknown AE | 20 patients affected |
| Early Loading | Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected | Patients affected by AE | 35 patients affected |
| Early Loading | Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected | Patients affected by related/ unknown AE | 15 patients affected |