Microvascular Reactivity of the Gingiva Around Implant Born Crown

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513627
• Other study ID #: 4/2018
• Status: Recruiting
• Start date: May 28, 2018
• Est. completion date: April 2020

Study information

• Verified date: October 2019
• Source: Semmelweis University
• Contact: Réka Fazekas
• Phone: +36 203514527
• Email: fazekas[@]medaker.hu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

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.

Locations

Country	Name	City	State
Hungary	Janos Vag	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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