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| ID | Type | Description | Link |
|---|---|---|---|
| D-2013-010 | Other Grant/Funding Number | Dentsply Sirona Implants |
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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
| Dental Practice, Malgorzata Pietruska, Jan Pietruski | OTHER |
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Evaluation of the marginal bone and soft tissue alterations after the OsseoSpeed™ EV Profile implants placement in anterior maxilla.
The following parameters will be tested:
Surgical procedures
Flap will be elevated following the crestal and releasing incisions (if necessary).
After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.
If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.
The flap will be sutured with 5/0 or 6/0 non-absorbable Ethilon sutures using the mattress and single interrupted sutures. Clinical photographs of the treated site after flap suturing will be taken.
Post-surgical instructions and follow-up
Check-ups and maintenance Appointments will be scheduled at weeks 1, 2, 4, and 6. Clinical photographs will be taken. During these appointments the presence of suppuration and flap dehiscence will be recorded dichotomously as presence/absence.
Uncovering procedure will be scheduled at 8 weeks post-op. After crestal incision and gentle flap elevation the height of denudated buccal implant surface (if present) will be measured using a periodontal probe. Then the healing abutment will be screwed in and single interrupted sutures will be placed with the use 5/0 or 6/0 non-absorbable Ethilon sutures (if necessary). Suture removal is planned 7 days after procedure. Clinical photographs will be taken.
Temporary crown will be delivered 3 months post implant placement. Clinical examination (PES, PI) will be performed. Photographs and control CBCT will be taken.
Final prosthetic reconstruction will be delivered 6 months post-op. Clinical examination (PES, PI) will be performed as well as clinical photographs will be taken.
1 year evaluation Clinical examination (PES, PI) will be performed. Clinical photographs of the study site will be taken. Control CBCT will be taken.
In case of any complication observed during any of the scheduled visit or during an emergency visit, intraoral radiographs and clinical photographs will be taken and the CRF will be filled in.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with implants | Experimental | Flap will be elevated following the crestal and releasing incisions (if necessary). After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height. If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation | Device | Soft tissue aesthetics, marginal bone level on CBCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pink Esthetic Score (PES) at Temporary Crown Delivery. | Pink Esthetic Score (PES): 0-10; minimum - 0, maximum - 10; the best outcome: 10 PES subscores: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, root convexity/soft tissue color and texture at the facial aspect of the implant site. Minimum 0, maximum - 2; the best outcome: 2 | value changes between examination carried out 3 and 9 months post-op |
| Papilla Index (PI) at Temporary Crown Delivery. | Papilla Index score: 0-4; the best outcome: 3; minimum: 0, maximum: 4 0 - no papilla present; 1 - less than half of the height of papilla present; 2 - half or more of the height of papilla is present but does not extend all the way up to the contact point between of the crowns; 3 - the papilla fill up the entire proximal space and is in good harmony with the adjacent palillae; 4 - the papilla is hyperplastic and covers too much of the implant restoration and/or the adjacent tooth | value changes between examination carried out 3 and 9 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Cone Beam Computed Tomography Examination Taken Right After Implant Installation. | Distance between implant collar and bone margin at buccal and palatal aspect of the crest evaluated on Cone Beam Computed Tomography examination (Pax-i3D Green; Vatech, South Korea). The change was calculated from two time points as the value at 12 months minus value at baseline. | Assessed immediately after implantation and 12 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Pietruski | Praktyka Stomatologiczna M. J. Pietruscy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Małgorzata Pietruska | Bialystok | Podlaskie Voivodeship | 15-269 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9497723 | Background | Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33. | |
| 19228100 | Background | Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group With Implants | Flap will be elevated following the crestal and releasing incisions (if necessary). After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height. If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below. Implantation: Soft tissue aesthetics, marginal bone level on Cone Beam Computed Tomography (CBCT). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group With Implants | Flap will be elevated following the crestal and releasing incisions (if necessary). After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height. If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below. Implantation: Soft tissue aesthetics, marginal bone level on CBCT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pink Esthetic Score (PES) at Temporary Crown Delivery. | Pink Esthetic Score (PES): 0-10; minimum - 0, maximum - 10; the best outcome: 10 PES subscores: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, root convexity/soft tissue color and texture at the facial aspect of the implant site. Minimum 0, maximum - 2; the best outcome: 2 | Posted | Median | Full Range | score on a scale | value changes between examination carried out 3 and 9 months post-op |
|
1 year
The definition of adverse event and/or serious adverse event didn't differ from the clinicaltrials.gov.
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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 | Group With Implants | Flap will be elevated following the crestal and releasing incisions (if necessary). After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height. If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below. Implantation: Soft tissue aesthetics, marginal bone level on CBCT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Małgorzata Pietruska | Medical University of Białystok | +48606461092 | mpietruska@wp.pl |
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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 | Sep 26, 2021 | Sep 26, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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case series
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Papilla Index (PI) at Temporary Crown Delivery. | Papilla Index score: 0-4; the best outcome: 3; minimum: 0, maximum: 4 0 - no papilla present; 1 - less than half of the height of papilla present; 2 - half or more of the height of papilla is present but does not extend all the way up to the contact point between of the crowns; 3 - the papilla fill up the entire proximal space and is in good harmony with the adjacent palillae; 4 - the papilla is hyperplastic and covers too much of the implant restoration and/or the adjacent tooth | Posted | Median | Full Range | score on a scale | value changes between examination carried out 3 and 9 months post-op |
|
|
|
|
| Secondary | Cone Beam Computed Tomography Examination Taken Right After Implant Installation. | Distance between implant collar and bone margin at buccal and palatal aspect of the crest evaluated on Cone Beam Computed Tomography examination (Pax-i3D Green; Vatech, South Korea). The change was calculated from two time points as the value at 12 months minus value at baseline. | Posted | Mean | Standard Deviation | mm | Assessed immediately after implantation and 12 months post-op |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| Median Difference (Final Values) |
| 1 |
| 2-Sided |
| Other |