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Marginal Bone and Soft Tissue Alterations After Use of OsseoSpeed EV Profile Implants

Primary Purpose

Alveolar Process Atrophy

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Implantation
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Process Atrophy focused on measuring implant, soft tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • lack of tooth in position of central incisors, canines and premolars

Exclusion Criteria:

  • Smoking
  • Uncontrolled diabetes
  • Pregnancy or lactation
  • Poor oral hygiene
  • Compromised dentition neighboring to edentulous site

Sites / Locations

  • Małgorzata Pietruska

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group with implants

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.

Full Information

First Posted
January 18, 2020
Last Updated
October 31, 2021
Sponsor
Medical University of Bialystok
Collaborators
Dentsply Sirona Implants and Consumables, Dental Practice, Malgorzata Pietruska, Jan Pietruski
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1. Study Identification

Unique Protocol Identification Number
NCT04243421
Brief Title
Marginal Bone and Soft Tissue Alterations After Use of OsseoSpeed EV Profile Implants
Official Title
Clinical and Radiographic Evaluation of the Marginal Bone and Soft Tissue Alterations After the Treatment With Use of OsseoSpeed EV Profile Implants: A Case Series Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Bialystok
Collaborators
Dentsply Sirona Implants and Consumables, Dental Practice, Malgorzata Pietruska, Jan Pietruski

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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: pink esthetic score - at the temporary crown delivery, at the final crown delivery, 6 months post final crown delivery papilla index - at the temporary crown delivery, at the final crown delivery, 6 months post final crown delivery changes in radiographic marginal bone levels and width at buccal and palatal aspects: differences between baseline (the day of surgery) and 1-year post-op measurements on CBCT will be made.
Detailed Description
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 Ibuprofen 400 mg 2-4 times per day will be prescribed in case of pain. In case of gastric problems it will be replaced by Paracetamol 1 g (max 4 g per day). Patient will be reminded to go on with the antibiotic prophylactic therapy as previously described. Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 3 weeks will be provided. Suture removal after 2 weeks. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Process Atrophy
Keywords
implant, soft tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group with implants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Implantation
Intervention Description
Soft tissue aesthetics, marginal bone level on CBCT
Primary Outcome Measure Information:
Title
Pink Esthetic Score (PES) at Temporary Crown Delivery.
Description
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
Title
Papilla Index (PI) at Temporary Crown Delivery.
Description
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
Secondary Outcome Measure Information:
Title
Cone Beam Computed Tomography Examination Taken Right After Implant Installation.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: lack of tooth in position of central incisors, canines and premolars Exclusion Criteria: Smoking Uncontrolled diabetes Pregnancy or lactation Poor oral hygiene Compromised dentition neighboring to edentulous site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Pietruski
Organizational Affiliation
Praktyka Stomatologiczna M. J. Pietruscy
Official's Role
Study Chair
Facility Information:
Facility Name
Małgorzata Pietruska
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-269
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9497723
Citation
Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
Results Reference
background
PubMed Identifier
19228100
Citation
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.
Results Reference
background

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Marginal Bone and Soft Tissue Alterations After Use of OsseoSpeed EV Profile Implants

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