Marginal Bone and Soft Tissue Alterations After Use of OsseoSpeed EV Profile Implants
NCT ID: NCT04243421
Last Updated: 2021-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2016-02-01
2020-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 CBCT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Implantation
Soft tissue aesthetics, marginal bone level on CBCT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Uncontrolled diabetes
* Pregnancy or lactation
* Poor oral hygiene
* Compromised dentition neighboring to edentulous site
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dentsply Sirona Implants and Consumables
INDUSTRY
Dental Practice, Malgorzata Pietruska, Jan Pietruski
OTHER
Medical University of Bialystok
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Małgorzata Pietruska
professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Pietruski
Role: STUDY_CHAIR
Praktyka Stomatologiczna M. J. Pietruscy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Małgorzata Pietruska
Bialystok, Podlaskie Voivodeship, Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D-2013-010
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
N/ST/ZB/18/001/1164
Identifier Type: -
Identifier Source: org_study_id