NCT03513627

Brief Summary

Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

May 28, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

April 19, 2018

Last Update Submit

October 28, 2019

Conditions

Dental Implants

Keywords

periimplant soft tissuegingivahumanmicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Magnitude of the hyperemia after PORH test

    Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. The scale is an arbitrary unit (0-3000 LSPU); relative changes to the baseline measurement will be calculate.

    5min

Secondary Outcomes (3)

  • Longevity of the hyperemia after PORH test

    20min

  • Size of the hyperemia after PORH test

    20 min

  • Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.

    20 min

Study Arms (2)

Implant

Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at a dental implant born crown in the front region of the jaw

Procedure: Post-occlusive reactive hyperemia test (PORH test)

Tooth

Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at the contralateral natural tooth

Procedure: Post-occlusive reactive hyperemia test (PORH test)

Interventions

Post-occlusive reactive hyperemia test (PORH test)PROCEDURE

Compression is applied on the buccal side of the attached gingiva, perpendicular to the long axis of the natural or implant born crown 2 mm far from the gingival margin.

ImplantTooth

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy patients who are not taking medication, with healthy gingiva

You may qualify if:

  • Patient with single dental implant installed in the front region of the jaw at least 6 months ago. On the contralateral side a natural tooth is located.

You may not qualify if:

  • systemic disease
  • smoking
  • alcohol abuse
  • pregnancy
  • gingivitis
  • periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Janos Vag

Budapest, 1088, Hungary

RECRUITING

Central Study Contacts

Réka Fazekas

CONTACT

+36 203514527fazekas@medaker.hu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

May 28, 2018

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)