IgY Efficacy on Periodontitis Patients

Chronic Periodontitis Clinical Trial

Official title:

Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705885
• Other study ID #: RHM 14
• Status: Completed
• Phase: N/A
• First received: November 25, 2015
• Last updated: March 7, 2016
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: Immunology Research Institute in Gifu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Scientific and Ethic Board, National Hospital of Odonto-Stomatology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Dietary Supplement:
• lozenges containing IgY
Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
• Placebo IgY
Placebo IgY

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Immunology Research Institute in Gifu	National Hospital of Odonto-Stomatology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis	Outcome measurement is probing pocket depth (PD)	8 weeks	No
Primary	Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis	Outcome measurement is bleeding on probing (BOP)	8 weeks	No
Secondary	Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis	Outcome measurement is P. gingivalis level in periodontal pockets	8 weeks	No