Microvascular Reactivity of the Gingiva Around Implant Born Crown

• Conditions: Dental Implants
• Interventions: Procedure: Post-occlusive reactive hyperemia test (PORH test)

• Registration Number: NCT03513627
• Lead Sponsor: Semmelweis University

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.

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 Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Study Start: 2018-05-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30
• Primary Completion: 2019-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implant	Post-occlusive reactive hyperemia test (PORH test)	Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at a dental implant born crown in the front region of the jaw
Tooth	Post-occlusive reactive hyperemia test (PORH test)	Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at the contralateral natural tooth

Primary Outcome Measures

Name	Time	Method
Magnitude of the hyperemia after PORH test	5min	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.

Secondary Outcome Measures

Name	Time	Method
Longevity of the hyperemia after PORH test	20min	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.
Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.	20 min	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.
Size of the hyperemia after PORH test	20 min	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.

Trial Locations

Locations (1)

Janos Vag; 🇭🇺 Budapest, Hungary