Microvascular Reactivity of the Gingiva Around Implant Born Crown

Comparison of Microvascular Reactivity Assessed by Post-occlusive Reactive Hyperaemia Test in Gingiva at Natural Tooth and at Implant Borne Crown

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.

Study Overview

• Status: Unknown
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Post-occlusive reactive hyperemia test (PORH test)

Detailed Description

This study will examine the effects of implantation and peri-implant soft tissue shaping on the circulation and the regeneration processes of the human gingiva.

The primary aim is to determine the effect of a short term disruption of the blood flow in the gingiva next to an implant and the contralateral tooth, in order to compare the functionally active collateral circulation in the attached gingiva at these respective regions. Using Laser Speckle Contrast Imaging technique (LSCI), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term compression of the gingiva. The secondary aim is to assess and compare the time course of the restoration of the circulation on the affected areas. Further aims are to observe if the compensation capability of the circulation is influenced by gingival thickness (biotype) and patient's gender.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Réka Fazekas; Phone Number: +36 203514527; Email: fazekas@medaker.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Recruiting
    • Janos Vag
    • Contact: Janos Vag; Phone Number: +36209577245; Email: drvagjanos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy patients who are not taking medication, with healthy gingiva

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.
Tooth; Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at the contralateral natural tooth	Procedure: Post-occlusive reactive hyperemia test (PORH test); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longevity 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.	20min
Size of the hyperemia after PORH test	Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. LSCI can measure in several cm2 areas and display blood perfusion as color-coded images.	20 min
Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.	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.	20 min

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: microcirculation; human; periimplant soft tissue; gingiva
• Other Study ID Numbers: 4/2018

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