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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243421
Recruitment Status : Active, not recruiting
First Posted : January 28, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Dentsply Sirona Implants
Dental Practice, Malgorzata Pietruska, Jan Pietruski
Information provided by (Responsible Party):
Małgorzata Pietruska, Medical University of Bialystok

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.

Condition or disease Intervention/treatment Phase
Alveolar Process Atrophy Device: Implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: case series
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: 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.

Device: Implantation
Soft tissue aesthetics, marginal bone level on CBCT




Primary Outcome Measures :
  1. Pink esthetic score [ Time Frame: value changes between examination carried out 3 and 9 months post-op ]
    score: 0-10; the best outcome: 10

  2. Papilla index [ Time Frame: value changes between examination carried out 3 and 9 months post-op ]
    score: 0-4; the best outcome: 3


Secondary Outcome Measures :
  1. CBCT examination (Pax-i3D Green; Vatech, South Korea) [ Time Frame: after implantation; month: 3, 12 post-op ]
    Distance between implant collar and bone margin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243421


Locations
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Poland
Małgorzata Pietruska
Białystok, Podlaskie, Poland, 15-269
Sponsors and Collaborators
Medical University of Bialystok
Dentsply Sirona Implants
Dental Practice, Malgorzata Pietruska, Jan Pietruski
Investigators
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Study Chair: Jan Pietruski Praktyka Stomatologiczna M. J. Pietruscy
Publications:
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Responsible Party: Małgorzata Pietruska, professor, Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT04243421    
Other Study ID Numbers: N/ST/ZB/18/001/1164
D-2013-010 ( Other Grant/Funding Number: Dentsply Sirona Implants )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Małgorzata Pietruska, Medical University of Bialystok:
implant
soft tissue
Additional relevant MeSH terms:
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Alveolar Bone Loss
Atrophy
Pathological Conditions, Anatomical
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases