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

NCT04243421 | Completed Results

• 2 other identifiers: N/ST/ZB/18/001/1164D-2013-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Process Atrophy

Keywords

implant; soft tissue

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Cone Beam Computed Tomography Examination Taken Right After Implant Installation.

  Assessed immediately after implantation and 12 months post-op

Study Arms (1)

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.

Device: Implantation

Interventions

Implantation DEVICE

Soft tissue aesthetics, marginal bone level on CBCT

Group with implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Dentsply Sirona Implants and Consumables: collaborator
• Dental Practice, Malgorzata Pietruska, Jan Pietruski: collaborator

Study Sites (1)

Małgorzata Pietruska

Bialystok, Podlaskie Voivodeship, 15-269, Poland

Location

Related Publications (2)

• Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.

  PMID: 9497723 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.

  PMID: 19228100 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Małgorzata Pietruska
• Organization: Medical University of Białystok

mpietruska@wp.pl

+48606461092

Study Officials

• Jan Pietruski

  Praktyka Stomatologiczna M. J. Pietruscy

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: case series

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 28, 2020
• Study Start: February 1, 2016
• Primary Completion: August 19, 2019
• Study Completion: November 15, 2020
• Last Updated: November 2, 2021
• Results First Posted: January 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)