Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants
Primary Purpose
Peri-implant Mucositis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Repeated removal and re-placement of healing and prosthetic abutments
Sponsored by
About this trial
This is an interventional diagnostic trial for Peri-implant Mucositis focused on measuring Peri-implant Mucositis
Eligibility Criteria
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,
Sites / Locations
- Universita la SapienzaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implant abutments
Arm Description
implant abutments
Outcomes
Primary Outcome Measures
change from baseline to 8 weeks of gingival fluid production
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04415801
First Posted
May 24, 2020
Last Updated
June 3, 2020
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT04415801
Brief Title
Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants
Official Title
Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
Peri-implant Mucositis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implant abutments
Arm Type
Experimental
Arm Description
implant abutments
Intervention Type
Diagnostic Test
Intervention Name(s)
Repeated removal and re-placement of healing and prosthetic abutments
Intervention Description
Repeated removal and re-placement of healing and prosthetic abutments
Primary Outcome Measure Information:
Title
change from baseline to 8 weeks of gingival fluid production
Description
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).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renzo Guarnieri, MD DDS
Phone
+39 3425224458
Email
renzoguarnieri@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Renzo Guarnieri
Email
renzoguarnieri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renzo Guarnieri
Organizational Affiliation
University La Sapienza Roma Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universita la Sapienza
City
Roma
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renzi Guarnieri, MD DDS
Phone
+39 342 5224458
Email
renzoguarnieri@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33728493
Citation
Guarnieri R, Miccoli G, Reda R, Mazzoni A, Di Nardo D, Testarelli L. Laser microgrooved vs. machined healing abutment disconnection/reconnection: a comparative clinical, radiographical and biochemical study with split-mouth design. Int J Implant Dent. 2021 Mar 17;7(1):19. doi: 10.1186/s40729-021-00301-6.
Results Reference
derived
Learn more about this trial
Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants
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