Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedJune 5, 2020
May 1, 2020
1 month
May 24, 2020
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
8 weeks
Study Arms (1)
Implant abutments
EXPERIMENTALimplant abutments
Interventions
Repeated removal and re-placement of healing and prosthetic abutments
Eligibility Criteria
You may qualify if:
- years or older, in good general health, and with sufficient amount of bone available to place a standard implant
You may not qualify if:
- natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universita la Sapienza
Roma, 00100, Italy
Related Publications (1)
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.
PMID: 33728493DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Renzo Guarnieri
University La Sapienza Roma Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor
Study Record Dates
First Submitted
May 24, 2020
First Posted
June 4, 2020
Study Start
May 1, 2020
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
June 5, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share