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Completed

NCT Number: NCT02705885

IgY Efficacy on 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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lozenges containing IgY

Dietary Supplement

Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy

Placebo IgY

Dietary Supplement

Placebo IgY

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Immunology Research Institute in Gifu

Industry

Collaborators

  • National Hospital of Odonto-Stomatology

Registry information

Official study title

Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 11, 2016
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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