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CompletedNCT02705885Updated Mar 11, 2016

IgY Efficacy on Periodontitis Patients

An interventional study of lozenges containing IgY and Placebo IgY in Chronic Periodontitis, sponsored by Immunology Research Institute in Gifu. Completed. Per ClinicalTrials.gov, last updated 2016-03-11.

Sponsored by Immunology Research Institute in Gifu · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Periodontitis

Keywords

  • IgY
  • Periodontitis
  • Porphyromonas gingivalis
  • gingipains
  • Efficacy
03

In context

Chronic Periodontitis

386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.

This study's enrollment of 60 is above the median of 46 across 314 interventional studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

Immunology Research Institute in Gifu is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
  • had allergy to egg proteins
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Gingipain IgY

    Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis

    Dietary Supplement: lozenges containing IgY

  • Placebo comparator
    Placebo IgY

    Participants consume lozenges containing placebo IgY

    Dietary Supplement: Placebo IgY

Interventions

  • Dietary supplementlozenges containing IgY

    Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy

  • Dietary supplementPlacebo IgY

    Placebo IgY

06

What researchers measure

Primary outcomes

  1. Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis

    Outcome measurement is probing pocket depth (PD)

    Time frame: 8 weeks

  2. Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis

    Outcome measurement is bleeding on probing (BOP)

    Time frame: 8 weeks

Secondary outcomes

  1. Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis

    Outcome measurement is P. gingivalis level in periodontal pockets

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02705885
Lead sponsor
Immunology Research Institute in Gifu
Collaborators
National Hospital of Odonto-Stomatology
Responsible party
Sponsor
First posted
Mar 11, 2016
Start date
Jun 2014
Primary completion
Aug 2014
Completion
Mar 2015
Last update
Mar 11, 2016

Study contacts

Thi Hong Minh Nguyen, Ph. D
principal investigator · National Hospital of Odonto-Stomatology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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