Back to resultsIgY Efficacy on Periodontitis Patients
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lozenges containing IgY
Placebo IgY
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Periodontitis focused on measuring IgY, Periodontitis, Porphyromonas gingivalis, gingipains, Efficacy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gingipain IgY
Placebo IgY
Arm Description
Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis
Participants consume lozenges containing placebo IgY
Outcomes
Primary Outcome Measures
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
Outcome measurement is probing pocket depth (PD)
Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
Outcome measurement is bleeding on probing (BOP)
Secondary Outcome Measures
Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
Outcome measurement is P. gingivalis level in periodontal pockets
Full Information
NCT ID
NCT02705885
First Posted
November 25, 2015
Last Updated
March 7, 2016
Sponsor
Immunology Research Institute in Gifu
Collaborators
National Hospital of Odonto-Stomatology
1. Study Identification
Unique Protocol Identification Number
NCT02705885
Brief Title
IgY Efficacy on Periodontitis Patients
Official Title
Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunology Research Institute in Gifu
Collaborators
National Hospital of Odonto-Stomatology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
IgY, Periodontitis, Porphyromonas gingivalis, gingipains, Efficacy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gingipain IgY
Arm Type
Experimental
Arm Description
Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis
Arm Title
Placebo IgY
Arm Type
Placebo Comparator
Arm Description
Participants consume lozenges containing placebo IgY
Intervention Type
Dietary Supplement
Intervention Name(s)
lozenges containing IgY
Intervention Description
Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo IgY
Intervention Description
Placebo IgY
Primary Outcome Measure Information:
Title
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
Description
Outcome measurement is probing pocket depth (PD)
Time Frame
8 weeks
Title
Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
Description
Outcome measurement is bleeding on probing (BOP)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
Description
Outcome measurement is P. gingivalis level in periodontal pockets
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thi Hong Minh Nguyen, Ph. D
Organizational Affiliation
National Hospital of Odonto-Stomatology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
IgY Efficacy on Periodontitis Patients
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