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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN67349927 |
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Date of registration:
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28/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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P. gingivalis passive immunization using egg yolk antibodies
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Scientific title:
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The effects of anti-porphyromonas gingivalis egg yolk antibodies in patients with periodontal disease |
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Date of first enrolment:
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01/05/2008 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN67349927 |
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Study type:
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Interventional |
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Study design:
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Randomized double-blind placebo controlled study (Treatment)
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Naoyuki
Sugano |
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Address:
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1-8-13 Kanda-Surugadai
101-8310
Chiyoda-ku, Tokyo
Japan |
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. At least 2 sites of peridontal disease
Exclusion criteria: 1. Less than 20 teeth
2. Taking medicine
3. Systematic disease
4. Food allergy
5. Need dental treatment
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontal disease
Oral Health
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Intervention(s)
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Eligible subjects (mean age, 51.0 ± 8.5 years; range, 36-66 years) were allocated randomly to the test and control groups according to gender, age, and smoking status, using a randomization table. All subjects had at least two probing pockets with a depth of =4 mm and bled after probing. All participants provided written informed consent. The study protocol was a double-blind placebo-controlled trial and approved by the Nihon University School of Dentistry Institutional Review Board. The randomization code was revealed when all microbiological and clinical data were gathered after the 12-week intervention period. Participants were instructed not to change their oral hygiene regimens, and tooth brushing instruction was not given during or before the experimental period.
Clinical measurements were obtained for Ramfjord’s six teeth (16, 21, 24, 36, 41, and 44 in the FDI two-digit notation system) in all subjects). The deepest probing depth (DPD), mean probing depth (PD), bleeding on probing (BOP), and O’Leary plaque control record (PCR) were recorded. When one of the selected teeth was missing from the oral cavity, data were obtained from an adjacent tooth in the same area of the jaw. Two weeks after the first clinical measurement, all participants received full-mouth scaling and root planning, followed by professional mechanical tooth cleaning (PMTC). All procedures were performed by two trained periodontists. After that, the subjects in the test (IgY-GP) group took tablets containing anti-gingipain egg yolk antibodies (100 mg/tablet), without chewing, three times a day after a meal or brushing. Tablets stayed in the mouth for 3 to 5 minutes. Eight hours after two minutes mouth rinse with egg yolk immunoglobulin, active antibodies detected in the saliva from 18 of 19 subjects. The subjects in the control group took placebo tablets containing non-immunized egg yolk antibodies in the same manner.
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Primary Outcome(s)
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Periodontal tissue conditions
Measured at baseline, 4 weeks and 12 weeks.
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Secondary Outcome(s)
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Periodontopathic bacterial number
Measured at baseline, 4 weeks and 12 weeks.
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Source(s) of Monetary Support
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Sato Fund, Nihon University School of Dentistry (Japan), Ministry of Education, Culture, Sports, Science and Technology-Japan
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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