Trial Outcomes & Findings for Marginal Bone and Soft Tissue Alterations After Use of OsseoSpeed EV Profile Implants (NCT NCT04243421)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

value changes between examination carried out 3 and 9 months post-op

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group With Implants n=30 Participants 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
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=30 Participants
Age, Categorical >=65 years	1 Participants n=30 Participants
Sex: Female, Male Female	19 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=30 Participants
Region of Enrollment Poland	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: value changes between examination carried out 3 and 9 months post-op

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

Outcome measures

Outcome measures
Measure	Group With Implants n=30 Participants 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
Pink Esthetic Score (PES) at Temporary Crown Delivery. Mesial papilla	1 score on a scale Interval 0.0 to 1.0
Pink Esthetic Score (PES) at Temporary Crown Delivery. Distal papilla	1 score on a scale Interval 0.0 to 1.0
Pink Esthetic Score (PES) at Temporary Crown Delivery. Curvature of the facial mucosa	1 score on a scale Interval 0.5 to 2.0
Pink Esthetic Score (PES) at Temporary Crown Delivery. Level of the facial mucosa	1 score on a scale Interval 0.5 to 2.0
Pink Esthetic Score (PES) at Temporary Crown Delivery. Root convexity/soft tissue color and texture	1 score on a scale Interval 1.0 to 2.0
Pink Esthetic Score (PES) at Temporary Crown Delivery. Pink Esthetic Score	5 score on a scale Interval 3.0 to 8.0

PRIMARY outcome

Timeframe: value changes between examination carried out 3 and 9 months post-op

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

Outcome measures

Outcome measures
Measure	Group With Implants n=30 Participants 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
Papilla Index (PI) at Temporary Crown Delivery. Mesial papilla	1 score on a scale Interval 0.0 to 2.0
Papilla Index (PI) at Temporary Crown Delivery. Distal papilla	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Assessed immediately after implantation and 12 months post-op

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.

Outcome measures

Outcome measures
Measure	Group With Implants n=30 Participants 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
Cone Beam Computed Tomography Examination Taken Right After Implant Installation.	1.99 mm Standard Deviation 1.05

Adverse Events

Group With Implants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Małgorzata Pietruska

Medical University of Białystok

Phone: +48606461092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place