Status:
WITHDRAWN
Evaluation of Two Active Lactobacilli for the Maintenance of Gingival Health
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Symrise AG
Conditions:
Gingivitis
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief Summary
The objective of the study will be to demonstrate the effects of two active lactobacilli (A/B) and determine whether there are any changes in plaque accumulation, gingival health, immunological and mi...
Detailed Description
This is a single centre, randomised, double-blind, parallel group study (3-Arm) of healthy subjects aged 18-30 years designed to demonstrate whether two active lactobacilli in the Experimental Gingivi...
Eligibility Criteria
Inclusion
- Informed Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age Aged 18-30 years.
- Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health Healthy volunteer
- Good general and mental health, in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities of medical history or physical and oral examination.
- Absence of any condition that would impact on the subject's safety, or wellbeing, or affect the individual's ability to understand the study procedures and requirements.
- Contraception Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. To exclude any confounding effects of pregnancy related changes in dental health. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. Following consent, Females will be required to use a pregnancy test kit administered at the study centre at Visit 1, results will be recorded on the relevant Case Report Form (CRF) and treated in confidence.
- Dental Requirements At least eight teeth in the lower jaw with a minimum of 4 teeth in each quadrant BPE scores 0-2 in the lower (mandible) jaw Bleeding Score of \<15% of sites in the lower (mandible) jaw (BOP) Following the dental prophylaxis, participants should have little or no gingival inflammation (\<1) in the lower (mandible) jaw as assessed by MGI.
- General Requirement Agree not to consume any other probiotic or yoghurt products during the study. Agree not to chew chewing gum during the study.
Exclusion
- Any inclusion criteria not met
- Any disease which in the investigator's opinion could affect the participant's response to treatment, including in particular:
- Diabetes mellitus Type I and II
- Presence or recent history of infectious diseases such as AIDS, Hepatitis and tuberculosis or other respiratory infections including those that can be transmitted in saliva.
- Bronchitis, tonsillitis or sinusitis.
- Substance abuse e.g. smoking or chewing of tobacco or paan, drugs and alcoholism. E-cigarettes will also be excluded
- Recent use of antibiotics and/or anti-inflammatory medication (within 4 weeks of visit).
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Allergy/Intolerance to the test and placebo products (ingredients) in particular lactose and milk protein content (allergens) in the test products.
- Evidence of chronic periodontitis (BPE score \>3 in any sextant of the lower jaw)
- Bleeding Score of \>15% of sites in the lower (mandible) jaw
- MGI Score of \>1 (mean) in the lower (mandible) jaw
- Currently ongoing treatment for chronic periodontitis
- Currently using an anti-microbial mouth rinse
- Participation in another clinical study or receipt of an investigational drug within 60 days of the screening visit.
- Previous participation in this study.
- Clinical dental students (2-5 years) will be excluded.
- Ongoing or planned elective dental treatment involving endodontic treatment and crown and bridge preparation.
- Furthermore, any participant requiring to undergo any emergency dental treatment during the study period will be assessed to determine whether they should continue to participate or be excluded.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03291327
Start Date
March 1 2018
End Date
October 1 2018
Last Update
March 7 2018
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