Microvascular Reactivity of the Gingiva Around Implant Born Crown

NCT ID: NCT03513627

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-28

Study Completion Date

2020-04-30

Brief Summary

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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

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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.

Conditions

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Dental Implants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Implant

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

Post-occlusive reactive hyperemia test (PORH test)

Intervention Type 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.

Tooth

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

Post-occlusive reactive hyperemia test (PORH test)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Janos Vag

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Réka Fazekas

Role: CONTACT

+36 203514527

Facility Contacts

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Janos Vag

Role: primary

+36209577245

Other Identifiers

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4/2018

Identifier Type: -

Identifier Source: org_study_id

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