Herbal Pralines - Oral Health

NCT ID: NCT06090851

Last Updated: 2024-07-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-01-31

Brief Summary

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This randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (Bleeding on probing) without an accompanied professional mechanical plaque removal.

Detailed Description

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Conditions

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Periodontitis Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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verum

pralines containing nitrate 3x day (200mg nitrate per day)

Group Type ACTIVE_COMPARATOR

herbal nitrate Pralines with nitrate

Intervention Type DIETARY_SUPPLEMENT

consumption of herbal pralines with nitrate

placebo

pralines without nitrate

Group Type PLACEBO_COMPARATOR

herbal nitrate Pralines without nitrate

Intervention Type DIETARY_SUPPLEMENT

consumption of herbal pralines without nitrate

Interventions

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herbal nitrate Pralines with nitrate

consumption of herbal pralines with nitrate

Intervention Type DIETARY_SUPPLEMENT

herbal nitrate Pralines without nitrate

consumption of herbal pralines without nitrate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* age 18 to 65 years,
* minimum of 20 % of the measure points showing a manifest bleeding after probing,
* no periodontal maintenance therapy within the past 4 months,
* a minimum of 10 remaining natural teeth

Exclusion Criteria

* history of drug / alcohol abuse,
* systemic intake of antibiotics \< 6 months prior to the study period,
* regular use of anti-inflammatory drugs,
* regular use of antibacterial mouthwashes,
* known allergic reactions to any ingredient in the experimental pralines
* mean arterial blood pressure MAD \<80mmHg
* known allergies and intolerances to any of the ingredients of the experimental pralines
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Yvonne Jockel-Schneider

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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German Naval Medical Institute

Kronshagen, , Germany

Site Status

Section of Periodontology

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NAVNIT_23

Identifier Type: -

Identifier Source: org_study_id

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