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

Alveolar Process Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243421
• Other study ID #: N/ST/ZB/18/001/1164
• Secondary ID: D-2013-010
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: November 15, 2020

Study information

• Verified date: October 2021
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2020
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Process Atrophy
• Atrophy

Intervention

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

Locations

Country	Name	City	State
Poland	Malgorzata Pietruska	Bialystok	Podlaskie

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Bialystok	Dental Practice, Malgorzata Pietruska, Jan Pietruski, Dentsply Sirona Implants

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Belser UC, Grütter 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 . — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Assessed immediately after implantation and 12 months post-op