Immediate Dental Implant Loading
Conditions
Brief summary
The purpose of this prospective randomized clinical study was to compare implant survival, patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of follow-up.
Detailed description
Purpose: The objective of the present prospective randomized clinical study was to compare the overall treatment outcome following immediate loading (IL) and delayed loading (DL) of single implants after 5 year of follow-up. Patients with a missing maxillary tooth (15-25) were randomly assigned to IL or DL. The protocol included implant installation in healed sites, immediate loading, delayed loading, temporary screw-retained restoration, and replacement with a permanent single implant crown. Outcome measures were implant survival, marginal bone level, soft tissue changes, papillae index, pink, and white esthetic score (PES and WES), patient judged aesthetics, and oral health impact profile (OHiP-14).
Interventions
PROCEDUREImmediate loading
PROCEDUREDelayed loading
Sponsors
Folktandvården Skåne AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients of at least 18 years of age. * In need of one or more single-tooth replacements. * The single-tooth replacement needs to be in the anterior maxilla * Minimum of mesial-distal width of interdental space of 6 mm
Exclusion criteria
* General contraindications for oral surgery * Inadequate oral hygiene * Insufficient bone volume at the recipient site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of Marginal Bone | Baseline to 12 months | Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline. |
| Pink Esthetic Score | After 12 months | The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome. |
| Oral Health Impact Profile 14 | Pre-surgery | The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life. |
| White Esthetic Score | Baseline | The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome. |
| Oral Health Impact Profile 14 (OHIP-14) | After 12 months | The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Loading Immediate loading with a screw-retained temporary crown and replacement with a permanent crown. | 25 |
| Delayed Loading Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Delayed Loading | Immediate Loading | Total |
|---|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 15.5 | 40.8 years STANDARD_DEVIATION 13.3 | 40.9 years STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 19 Participants | 11 Participants | 30 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 |
Outcome results
Primary
Change in Level of Marginal Bone
Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.
Time frame: Baseline to 12 months
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Change in Level of Marginal Bone | -0.57 mm | Standard Deviation 0.52 |
| Delayed Loading | Change in Level of Marginal Bone | -0.69 mm | Standard Deviation 0.69 |
Primary
Change in Level of Marginal Bone
Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.
Time frame: Baseline to 5 years
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.~1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Change in Level of Marginal Bone | -0.50 mm | Standard Deviation 0.73 |
| Delayed Loading | Change in Level of Marginal Bone | -0.54 mm | Standard Deviation 0.65 |
Primary
Oral Health Impact Profile 14
The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life.
Time frame: Pre-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Oral Health Impact Profile 14 | 26.68 units on a scale | Standard Deviation 9.3 |
| Delayed Loading | Oral Health Impact Profile 14 | 23.40 units on a scale | Standard Deviation 8.64 |
Primary
Oral Health Impact Profile 14 (OHIP-14)
The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life.
Time frame: After 12 months
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Oral Health Impact Profile 14 (OHIP-14) | 16.48 units on a scale | Standard Deviation 3.87 |
| Delayed Loading | Oral Health Impact Profile 14 (OHIP-14) | 15.38 units on a scale | Standard Deviation 2.58 |
Primary
Pink Esthetic Score
The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.
Time frame: Baseline
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Pink Esthetic Score | 8.56 score on a scale | Standard Deviation 2.27 |
| Delayed Loading | Pink Esthetic Score | 9.42 score on a scale | Standard Deviation 2.98 |
Primary
Pink Esthetic Score
The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.
Time frame: After 12 months
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Pink Esthetic Score | 10.36 units on a scale | Standard Deviation 2.46 |
| Delayed Loading | Pink Esthetic Score | 10.67 units on a scale | Standard Deviation 2.32 |
Primary
Pink Esthetic Score
The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.
Time frame: After 5 year
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.~1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Pink Esthetic Score | 11.00 Score on a scale | Standard Deviation 2.08 |
| Delayed Loading | Pink Esthetic Score | 11.17 Score on a scale | Standard Deviation 2.39 |
Primary
White Esthetic Score
The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.
Time frame: Baseline
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | White Esthetic Score | 7.00 units on a scale | Standard Deviation 1.41 |
| Delayed Loading | White Esthetic Score | 7.00 units on a scale | Standard Deviation 1.64 |
Primary
White Esthetic Score
The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.
Time frame: After 12 months
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | White Esthetic Score | 7.76 Score on a scale | Standard Deviation 1.3 |
| Delayed Loading | White Esthetic Score | 7.87 Score on a scale | Standard Deviation 1.39 |
Primary
White Esthetic Score
The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.
Time frame: 5 years
Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.~1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | White Esthetic Score | 7.63 Score on a scale | Standard Deviation 1.53 |
| Delayed Loading | White Esthetic Score | 7.91 Score on a scale | Standard Deviation 1.53 |