Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Gingipain IgY
Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis
Intervention: lozenges containing IgY (Dietary Supplement)
Placebo IgY
Participants consume lozenges containing placebo IgY
Intervention: Placebo IgY (Dietary Supplement)
Outcomes
Primary Outcomes
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)
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
- Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis(8 weeks)