Osseointegration Failure of Dental Implant
Conditions
Brief summary
To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.
Interventions
PROCEDUREImmediate loading, fully guided surgery and 3D printed restoration
Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
PROCEDUREImmediate loading
Only subjected to immediate loading. Conventional procedure.
Sponsors
Folktandvården Skåne AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years of age who had signed an informed consent * in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.
Exclusion criteria
* general contraindications for oral surgery * patients with inadequate oral hygiene * need for bone grafting or ridge augmentation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Implant Survival | 12 months | Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction |
| MBL | 12 months | Marginal bone loss MBL, measured in mm from implant abutment junction. |
| Pink Esthetic Score | 12 months | Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome. |
| White Esthetic Score | 12 months | White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome. |
| Oral Health Impact Profile - 14 | 12 months | Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digital Immediate Loading Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded. | 21 |
| Immediate Loading Immediate loading: Only subjected to immediate loading. Conventional procedure. | 25 |
| Total | 46 |
Baseline characteristics
| Characteristic | Immediate Loading | Total | Digital Immediate Loading |
|---|---|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 13.3 | 40.5 years STANDARD_DEVIATION 17 | 40.2 years STANDARD_DEVIATION 21 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 25 participants | 46 participants | 21 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 25 |
| other Total, other adverse events | 0 / 21 | 0 / 25 |
| serious Total, serious adverse events | 2 / 21 | 0 / 25 |
Outcome results
Primary
MBL
Marginal bone loss MBL, measured in mm from implant abutment junction.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Immediate Loading | MBL | -0.40 mm | Standard Deviation 0.41 |
| Immediate Loading | MBL | -0.57 mm | Standard Deviation 0.52 |
Primary
Number of Participants With Implant Survival
Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Digital Immediate Loading | Number of Participants With Implant Survival | 19 participants |
| Immediate Loading | Number of Participants With Implant Survival | 25 participants |
Primary
Oral Health Impact Profile - 14
Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Immediate Loading | Oral Health Impact Profile - 14 | 17.10 score on a scale | Standard Deviation 3.23 |
| Immediate Loading | Oral Health Impact Profile - 14 | 16.48 score on a scale | Standard Deviation 3.87 |
Primary
Pink Esthetic Score
Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Immediate Loading | Pink Esthetic Score | 10.53 score on a scale | Standard Deviation 2.04 |
| Immediate Loading | Pink Esthetic Score | 10.36 score on a scale | Standard Deviation 2.46 |
Primary
White Esthetic Score
White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Immediate Loading | White Esthetic Score | 7.79 score on a scale | Standard Deviation 1.36 |
| Immediate Loading | White Esthetic Score | 7.76 score on a scale | Standard Deviation 1.3 |