IgY Efficacy on Periodontitis Patients
Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2016
CompletedMarch 11, 2016
March 1, 2016
2 months
November 25, 2015
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
Outcome measurement is probing pocket depth (PD)
8 weeks
Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
Outcome measurement is bleeding on probing (BOP)
8 weeks
Secondary Outcomes (1)
Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
8 weeks
Study Arms (2)
Gingipain IgY
EXPERIMENTALParticipants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis
Placebo IgY
PLACEBO COMPARATORParticipants consume lozenges containing placebo IgY
Interventions
Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
- had allergy to egg proteins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thi Hong Minh Nguyen, Ph. D
National Hospital of Odonto-Stomatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
March 11, 2016
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
March 1, 2015
Last Updated
March 11, 2016
Record last verified: 2016-03