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| ID | Type | Description | Link |
|---|---|---|---|
| Dnr 2011/125 | Other Identifier | Regional Ethical Review Board in Lund |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate loading | Experimental | Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion |
|
| Delayed loading | Active Comparator | Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate loading | Procedure |
| ||
| Delayed loading |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 months |
| 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. | After 12 months |
| 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. | Pre-surgery |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Wennerberg, DDS, Phd | Malmö University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Dental Specialist Care | Malmö | Skåne County | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Loading | Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion Immediate loading |
| FG001 | Delayed Loading | Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown. Delayed loading |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Loading | Immediate loading with a screw-retained temporary crown and replacement with a permanent crown. |
| BG001 | Delayed Loading | Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mm | Baseline to 12 months |
|
1 year
Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Loading | Immediate loading with a screw-retained temporary crown and replacement with a permanent crown. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental implant loss | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Björn Gjelvold | Folktandvården Skåne AB | +46709467870 | bjorn.gjelvold@gmail.com |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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|
| Baseline |
| 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. | Baseline |
| 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. | After 12 months |
| 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. | After 12 months |
| 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. | Baseline to 5 years |
| 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. | After 5 year |
| 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. | 5 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | After 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-surgery |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | After 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | After 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mm | Baseline to 5 years |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | After 5 year |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 5 years |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Delayed Loading | Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown. | 1 | 25 | 0 | 25 |
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| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |