An interventional study of Implantation in Alveolar Process Atrophy, sponsored by Medical University of Bialystok. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Treatment
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.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 30 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Implantation
Soft tissue aesthetics, marginal bone level on CBCT
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
Time frame: 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
Time frame: value changes between examination carried out 3 and 9 months post-op
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.
Time frame: Assessed immediately after implantation and 12 months post-op
| Milestone | Group With Implants |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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
| score on a scale | Group With Implants |
|---|---|
| Mesial papilla | 1 (0 to 1) |
| Distal papilla | 1 (0 to 1) |
| Curvature of the facial mucosa | 1 (0.5 to 2) |
| Level of the facial mucosa | 1 (0.5 to 2) |
| Root convexity/soft tissue color and texture | 1 (1 to 2) |
| Pink Esthetic Score | 5 (3 to 8) |
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
| score on a scale | Group With Implants |
|---|---|
| Mesial papilla | 1 (0 to 2) |
| Distal papilla | 1 (0 to 2) |
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.
| mm | Group With Implants |
|---|---|
| Cone Beam Computed Tomography Examination Taken Right After Implant Installation. | 1.99 ± 1.05 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group With Implants | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Group With Implants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Group With Implants |
|---|---|
| Female | 19 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Group With Implants |
|---|
| Region of Enrollment(Participants) | Group With Implants |
|---|---|
| Poland | 30 |
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Medical University of Bialystok