Chronic PeriodontitisNCT02705885
IgY Efficacy on Periodontitis Patients
A study testing lozenges containing IgY in people with Chronic Periodontitis, run by Immunology Research Institute in Gifu.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- lozenges containing IgY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
- had allergy to egg proteins
About this study
Official title: Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
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.
- Conditions
- Chronic Periodontitis
- Being tested
- lozenges containing IgY, Placebo IgY
- Keywords
- IgY, Periodontitis, Porphyromonas gingivalis, gingipains, Efficacy
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lozenges containing IgYDietary supplement
Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
Placebo IgYDietary supplement
Placebo IgY
| Study group | Role | What they receive |
|---|---|---|
| Gingipain IgY | Experimental | Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis Receives: Dietary Supplement: lozenges containing IgY |
| Placebo IgY | Placebo comparator | Participants consume lozenges containing placebo IgY Receives: Dietary Supplement: Placebo IgY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
Outcome measurement is probing pocket depth (PD)
Measured: 8 weeks
Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
Outcome measurement is bleeding on probing (BOP)
Measured: 8 weeks
Secondary outcomes (1)
Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
Outcome measurement is P. gingivalis level in periodontal pockets
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunology Research Institute in Gifu
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Hospital of Odonto-Stomatology
- Responsible party
- Sponsor
- Investigators
- Thi Hong Minh Nguyen, Ph. D, Principal investigator, National Hospital of Odonto-Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705885
- Sponsor's protocol ID
- RHM 14
- Status last verified
- Mar 2016
- First submitted
- 25 Nov 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
- ClinicalTrials.gov ID
- NCT02705885
- Acronym / sponsor ID
- RHM 14
- Conditions
- Chronic Periodontitis
- Keywords
- IgY, Periodontitis, Porphyromonas gingivalis, gingipains, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Immunology Research Institute in GifuIndustry (pharma, biotech, devices)
- Collaborators
- National Hospital of Odonto-Stomatology
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingipain IgY | Experimental | Dietary Supplement: lozenges containing IgYParticipants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis |
| Placebo IgY | Placebo comparator | Dietary Supplement: Placebo IgYParticipants consume lozenges containing placebo IgY |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
- had allergy to egg proteins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lozenges containing IgYPatients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy | Dietary supplement | Gingipain IgY |
| Placebo IgYPlacebo IgY | Dietary supplement | Placebo IgY |
Primary outcome
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)
1 secondary outcome
Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi Hong Minh Nguyen, Ph. D principal investigator
National Hospital of Odonto-Stomatology
Questions about this trial
What is this clinical trial studying?
A study testing lozenges containing IgY in people with Chronic Periodontitis, run by Immunology Research Institute in Gifu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.