Evidence of Spreading Vasoconstriction in Human Gingiva
1 other identifier
interventional
29
1 country
1
Brief Summary
The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.
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 2019
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, 2019
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 2, 2020
July 1, 2020
7 months
October 16, 2019
July 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood flow change after application of epinephrine
The change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites
30 minutes
Secondary Outcomes (1)
Comparsion of the change in blood flow between genders
30 minutes
Other Outcomes (1)
Correlation between the change in blood flow and gingival thickness
5 minutes
Study Arms (2)
Epinephrine effect throught keratinized ginigva
EXPERIMENTAL1 mg/ml epniephrine vs physiologocal saline
Epinephrine effect throught gingival sulcular epithelium
EXPERIMENTAL1 mg/ml epniephrine vs physiologocal saline
Interventions
Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.
Eligibility Criteria
You may qualify if:
- at least 5 mm keratinized gingiva at the upper front teeth
- general health
You may not qualify if:
- pregnancy, breast-feeding
- any medication
- smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Janos Vag
Budapest, 1088, Hungary
Related Publications (1)
Vag J, Ganti B, Mikecs B, Szabo E, Molnar B, Lohinai Z. Epinephrine penetrates through gingival sulcus unlike keratinized gingiva and evokes remote vasoconstriction in human. BMC Oral Health. 2020 Nov 4;20(1):305. doi: 10.1186/s12903-020-01296-z.
PMID: 33148235DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 18, 2019
Study Start
May 1, 2019
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
July 2, 2020
Record last verified: 2020-07