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In this study, the investigators will examine the performance of a new dental implant that has been approved by the Food and Drug Administration for use to replace of missing teeth. The investigators will study two groups of patients: one group will receive a temporary crown to replace the missing tooth at the same day as implant surgery; the second group will receive a similar crown 3 months later. Both groups will receive a permanent crown on the implant 4 months after surgery, and will be followed up for a period of 12 months. The investigators want to examine whether the healing of the bone and gums surrounding the implant that receives a crown immediately is similar to the healing of the implant when the crown is delivered later. If this is indeed the case, then the investigators will be able to recommend faster treatment for all patients.
Dental implants are a widely used treatment option for the replacement of lost teeth due to trauma or oral diseases. The original protocol for placement of dental implants in edentulous spaces in the maxilla or the mandible was introduced more than thirty years ago and called for a two-stage approach, i.e., surgical placement of submerged dental implants and subsequent uncovering with abutment connection, prosthesis fabrication and functional loading approximately 6 months after. Today, the time between surgery and loading in a two-stage protocol has been commonly abbreviated to 3-4 months, while immediate implant provisionalization has emerged as a reliable and predictable option in cases of adequate osseous support, having similar survival and success rates to the two-step procedure. Comparison of histological healing has demonstrated no significant differences in bone to implant contact between implants surgically placed according to a two-stage protocol and those immediately provisionalized. However, substantial variability was noted among the clinical protocols used in the studies carried out so far, and additional well-designed randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of immediate and early loading protocols.
The design of dental implants is a subject of continuous improvement, and implant manufacturers regularly introduce new products the use of which may result in accelerated soft and hard tissue healing, increased initial implant stability, and enhanced aesthetic outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®) and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an internal conical connection. The implant is marketed under the premarket notifications K050406 and K073142 (510(k), Food and Drug Administration).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate provisionalization | Active Comparator | Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery |
|
| Delayed provisionalization | Active Comparator | Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate provisionalization | Procedure | Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Bone Level Mesial to the Implant | Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Baseline and 6 months |
| Radiographic Bone Level Mesial to the Implant | Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Baseline and 12 months |
| Radiographic Bone Level Distal to the Implant | Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Baseline and 6 months |
| Radiographic Bone Level Distal to the Implant | Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Peri-implant Mucosal Margin Level | Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure. | Baseline and 6 months |
| Mean Change in Peri-implant Mucosal Margin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panos N Papapanou, DDS, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University College of Dental Medicine | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6838955 | Background | Branemark PI, Adell R, Albrektsson T, Lekholm U, Lundkvist S, Rockler B. Osseointegrated titanium fixtures in the treatment of edentulousness. Biomaterials. 1983 Jan;4(1):25-8. doi: 10.1016/0142-9612(83)90065-0. | |
| 20467608 | Background | Esposito M, Grusovin MG, Chew YS, Coulthard P, Worthington HV. One-stage versus two-stage implant placement. A Cochrane systematic review of randomised controlled clinical trials. Eur J Oral Implantol. 2009 Summer;2(2):91-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
| FG001 | Delayed Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
| 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 | Radiographic Bone Level Mesial to the Implant | Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Only includes individuals with analyzable data. | Posted | Mean | Standard Deviation | Millimeters | Baseline and 6 months |
|
Up to 36 months from procedure
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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 Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prosthetic Screw Loosening - Multiple | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Panos N. Papapanou, DDS, PhD | Columbia University | (212) 342-3008 | pp192@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2015 | Jan 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003442 | Crowns |
| ID | Term |
|---|---|
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
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| Delayed provisionalization | Procedure | Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. |
|
| NobelParallel CC implant | Device | Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. |
|
|
| Dental crown | Device | A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
|
|
Measurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure.
| Baseline and 12 months |
| Mean Change in Peri-implant Mucosal Margin Level | Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure. | 6 months and 12 months |
| 8007025 | Background | Piattelli A, Ruggeri A, Franchi M, Romasco N, Trisi P. An histologic and histomorphometric study of bone reactions to unloaded and loaded non-submerged single implants in monkeys: a pilot study. J Oral Implantol. 1993;19(4):314-20. |
| 32757387 | Derived | Wang J, Lerman G, Bittner N, Fan W, Lalla E, Papapanou PN. Immediate versus delayed temporization at posterior single implant sites: A randomized controlled trial. J Clin Periodontol. 2020 Oct;47(10):1281-1291. doi: 10.1111/jcpe.13354. Epub 2020 Sep 4. |
| BG001 | Delayed Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Tooth Type | Count of Participants | Participants |
|
| Arch | Count of Participants | Participants |
|
| OG001 | Delayed Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. |
|
|
|
| Primary | Radiographic Bone Level Mesial to the Implant | Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Only includes individuals who completed the 1-year follow up. | Posted | Mean | Standard Deviation | Millimeters | Baseline and 12 months |
|
|
|
|
| Primary | Radiographic Bone Level Distal to the Implant | Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Only includes individuals with analyzable data. | Posted | Mean | Standard Deviation | Millimeters | Baseline and 6 months |
|
|
|
|
| Primary | Radiographic Bone Level Distal to the Implant | Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point. | Only includes individuals who completed the 1-year follow up. | Posted | Mean | Standard Deviation | Millimeters | Baseline and 12 months |
|
|
|
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| Secondary | Mean Change in Peri-implant Mucosal Margin Level | Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure. | Posted | Mean | Standard Deviation | millimeters of tissue | Baseline and 6 months |
|
|
|
|
| Secondary | Mean Change in Peri-implant Mucosal Margin Level | Measurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure. | Posted | Mean | Standard Deviation | millimeters | Baseline and 12 months |
|
|
|
|
| Secondary | Mean Change in Peri-implant Mucosal Margin Level | Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure. | Posted | Mean | Standard Deviation | millimeters | 6 months and 12 months |
|
|
|
|
| 4 |
| 26 |
| 0 |
| 26 |
| 4 |
| 26 |
| EG001 | Delayed Provisionalization | Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance. | 3 | 23 | 0 | 23 | 3 | 23 |
| Crown fracture | Product Issues | Non-systematic Assessment | Occurred 17 months after crown delivery |
|
| Prosthetic Screw Loosening - Single | Product Issues | Non-systematic Assessment | Occurred 16 months after crown delivery |
|
| Implant mobile/removed | General disorders | Non-systematic Assessment | Occurred 9 months after crown delivery |
|
| Cement - retained due to angle correction | General disorders | Non-systematic Assessment |
|
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| D004864 |
| Equipment and Supplies |