IgY Efficacy on Periodontitis Patients

March 7, 2016 updated by: Immunology Research Institute in Gifu

Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gingipain IgY
Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis
Dietary supplement: lozenges containing IgY
Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
PLACEBO_COMPARATOR: Placebo IgY
Participants consume lozenges containing placebo IgY
Dietary supplement: Placebo IgY
Placebo IgY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
Time Frame: 8 weeks
Outcome measurement is probing pocket depth (PD)
8 weeks
Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
Time Frame: 8 weeks
Outcome measurement is bleeding on probing (BOP)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
Time Frame: 8 weeks
Outcome measurement is P. gingivalis level in periodontal pockets
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunology Research Institute in Gifu

Collaborators

National Hospital of Odonto-Stomatology

Investigators

  • Principal Investigator: Thi Hong Minh Nguyen, Ph. D, National Hospital of Odonto-Stomatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

March 7, 2016

First Posted (ESTIMATE)

March 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM 14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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