- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415801
Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants
June 3, 2020 updated by: Renzo Guarnieri, University of Roma La Sapienza
Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants
Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues.
The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after functional loading, on proinflammatory cytokine levels around dental implants.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Twenty-four patients each received 2 one-stage implants in a split mouth design on the same jaw.
In each patient one healing and prosthetic abutments with a laser microgrooved surface (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS group) were used.
Four months following implant placement [Baseline (BSL)], the healing abutments were disconnnected and reconnected three times to carry out the impression procedures and metal framework try-in.
Four weeks later (T0), definitive prosthetic abutments were installated with screw retained crowns.
Samples for immunological analyses were taken from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1).
Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Renzo Guarnieri, MD DDS
- Phone Number: +39 3425224458
- Email: renzoguarnieri@gmail.com
Study Contact Backup
- Name: Renzo Guarnieri
- Email: renzoguarnieri@gmail.com
Study Locations
-
-
-
Roma, Italy, 00100
- Recruiting
- Università La Sapienza
-
Contact:
- Renzi Guarnieri, MD DDS
- Phone Number: +39 342 5224458
- Email: renzoguarnieri@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older, in good general health, and with sufficient amount of bone available to place a standard implant
Exclusion Criteria:
- natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implant abutments
implant abutments
|
Repeated removal and re-placement of healing and prosthetic abutments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline to 8 weeks of gingival fluid production
Time Frame: 8 weeks
|
The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Renzo Guarnieri, University La Sapienza Roma Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
May 31, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
May 24, 2020
First Submitted That Met QC Criteria
May 31, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
June 5, 2020
Last Update Submitted That Met QC Criteria
June 3, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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