Evaluation of Two Active Lactobacilli for the Maintenance of Gingival Health

NCT03291327 | Withdrawn DMC

• 1 other identifier: QMERC2017/36
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 microbial markers compared to a placebo (P) over a 2-week period of refraining from normal oral hygiene practice. This is a single centre, randomised, double-blind, parallel group study (3-Arm) of healthy subjects aged 18-30 years designed to demonstrate the effectiveness of two active lactobacilli using the experimental gingivitis Model: A proof of principle study on plaque, gingival status, immunological and microbial markers compared to placebo.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (3)

• Changes in gingival health status as indicated by changes in Gingival Bleeding Index (GBI)

  Changes in the gingival health status following the application of each test product will be performed using validated tools namely bleeding on probing (GBI) on test group subjects compared to placebo subjects. The presence or absence of bleeding will be scored within 30 seconds after probing with a Williams periodontal probe. Score Description 0 Absence of bleeding after 30 seconds. 1. Bleeding observed after 30 seconds. 2. Immediate bleeding observed.

  Baseline to +14 days

• Changes in gingival health status as indicated by changes in Quigley-Hein Plaque Index (Q-H)

  Changes in the gingival health status following the application of each test product will be performed using assessment of plaque accumulation (Q-H) on test group subjects compared to placebo subjects. All teeth in mandible excluding third molars will be scored with Quigley-Hein Plaque Index (Q-H). The teeth will be lightly dried a disclosing solution (PlaqueSearch TePe® TePe Munhygienprodukter, Malmo, Sweden) will be applied to all teeth in the mandible jaw. All teeth in the lower (mandible) jaw excluding 3rd molars will be visually scored using the Index, both buccal and lingual aspects of each tooth will be assessed. Score Description 0 No plaque. 1. Isolated areas of plaque at gingival margin. 2. Thin band of plaque at gingival margin (\< 1mm). 3. Plaque covering up to 1/3 of tooth surface. 4. Plaque covering 1/3 to 2/3 of tooth surface. 5. Plaque covering \> 2/3 of tooth surface.

  Baseline to +14 days

• Changes in gingival health status as indicated by changes in Modified Gingival Index (MGI)

  Changes in the gingival health status following the application of each test product will be performed using colour changes in the gingiva (MGI) of test group subjects compared to placebo subjects. All teeth in mandible excluding third molars will be scored with MGI Score Description 0 Absence of inflammation. 1. Mild inflammation; slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit. 2. Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit. 3. Moderate inflammation; glazing, redness, oedema, and/or hypertrophy of the marginal or papillary gingival unit. 4. Severe inflammation; marked redness, oedema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion or ulceration.

  Baseline to +14 days

Secondary Outcomes (2)

• Changes in Inflammatory Markers

  Baseline to + 14 days

• Changes in Bacterial Composition

  Baseline to + 14 days

Study Arms (3)

Investigational product (Lactobacillus A)

ACTIVE COMPARATOR

All volunteers considered to be suitable for the study will receive a pre-baseline dental prophylaxis. At baseline (BL) they will be instructed to abstain from all methods of tooth cleaning in mandible for 2 weeks (2W) apart from the fluoride toothpaste provided. A soft gum shield provided will cover the mandibular teeth whilst brushing and will be removed 10 minutes after brushing. Gingival health assessments and gingival crevicular fluid (GCF) and bacterial plaque samples be undertaken at BL and 2W. At 2W, all participants will receive a dental prophylaxis following the collection of samples and will be asked to resume their normal oral hygiene regime. Lactobacillus (A) in the form of a lozenge to be taken twice daily (in the morning and in the evening). The lactobacilli will be in the form of a lozenge, which should be placed on the tongue and allowed to dissolve. Any undissolved particles may be swallowed by the participant.

Dietary Supplement: Probiotics

Investigational product (Lactobacillus B)

ACTIVE COMPARATOR

All volunteers considered to be suitable for the study will receive a pre-baseline dental prophylaxis. At baseline (BL) they will be instructed to abstain from all methods of tooth cleaning in mandible for 2 weeks (2W) apart from the fluoride toothpaste provided. A soft gum shield provided will cover the mandibular teeth whilst brushing and will be removed 10 minutes after brushing. Gingival health assessments and gingival crevicular fluid (GCF) and bacterial plaque samples be undertaken at BL and 2W. At 2W, all participants will receive a dental prophylaxis following the collection of samples and will be asked to resume their normal oral hygiene regime. Lactobacillus (B) in the form of a lozenge to be taken twice daily (in the morning and in the evening). The lactobacilli will be in the form of a lozenge, which should be placed on the tongue and allowed to dissolve. Any undissolved particles may be swallowed by the participant.

Dietary Supplement: Probiotics

Placebo Product (P)

PLACEBO COMPARATOR

All volunteers considered to be suitable for the study will receive a pre-baseline dental prophylaxis. At baseline (BL) they will be instructed to abstain from all methods of tooth cleaning in mandible for 2 weeks (2W) apart from the fluoride toothpaste provided. A soft gum shield provided will cover the mandibular teeth whilst brushing and will be removed 10 minutes after brushing. Gingival health assessments and gingival crevicular fluid (GCF) and bacterial plaque samples be undertaken at BL and 2W. At 2W, all participants will receive a dental prophylaxis following the collection of samples and will be asked to resume their normal oral hygiene regime. Placebo (P) in the form of a lozenge to be taken twice daily (in the morning and in the evening). The placebo will be in the form of a lozenge, which should be placed on the tongue and allowed to dissolve. Any undissolved particles may be swallowed by the participant.

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Lozenges for Home use

Investigational product (Lactobacillus A); Investigational product (Lactobacillus B); Placebo Product (P)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Symrise AG: collaborator

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study randomisation schedule will be provided by an independent statistician in a sealed envelope and will be kept in a Study Master File (Test Products). The study blind will only be broken in an emergency where it was essential to know which formulation a participant had received in order to give the appropriate medical care. In the event of the requirement to break the code, the investigator (or designee) will, where possible, contact the Sponsor prior to breaking the blind. The investigator will then sign and date the broken code envelope and document the reason for breaking the code. All study products will be provided by the Sponsor, in blister packs pre-labelled with randomisation numbers according the Sponsor's randomisation schedule. Toothpaste with Fluoride (Colgate/Crest) together will also be provided.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Centre parallel arm (3) double blind placebo controlled study

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: March 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share