IgY Efficacy on Periodontitis Patients

NCT ID: NCT02705885

Last Updated: 2016-03-11

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8 weeks the patients were examined against. Parameters including probing depth (PD), bleeding on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared to the control group that had used placebo lozenges.

Detailed Description

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Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gingipain IgY

Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis

Group Type EXPERIMENTAL

lozenges containing IgY

Intervention Type DIETARY_SUPPLEMENT

Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy

Placebo IgY

Participants consume lozenges containing placebo IgY

Group Type PLACEBO_COMPARATOR

Placebo IgY

Intervention Type DIETARY_SUPPLEMENT

Placebo IgY

Interventions

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lozenges containing IgY

Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy

Intervention Type DIETARY_SUPPLEMENT

Placebo IgY

Placebo IgY

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with chronic periodontitis
* had at least 2 interproximal site with pocket depth between 3 mm to 5 mm
* nonsmokers with at least 20 natural teeth
* bone loss and bleeding on probing
* had not undergone periodontal treatments within 6 weeks before the study

Exclusion Criteria

* patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
* had allergy to egg proteins
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hospital of Odonto-Stomatology

OTHER

Sponsor Role collaborator

Immunology Research Institute in Gifu

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thi Hong Minh Nguyen, Ph. D

Role: PRINCIPAL_INVESTIGATOR

National Hospital of Odonto-Stomatology

Other Identifiers

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RHM 14

Identifier Type: -

Identifier Source: org_study_id

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