An interventional study of Probiotics in Gingivitis, sponsored by Queen Mary University of London. Withdrawn. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Prevention
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.
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 Gingivitis Model modify plaque accumulation, gingival status, immunological and microbial markers compared to placebo. Participants will be screened at a pre-baseline visit by a Study Dentist to determine their suitability for the study which will include healthy volunteers and exclude subjects with initial signs of gingival inflammation. Those volunteers considered to be suitable for the study will receive a pre-baseline dental prophylaxis. Participants will be required to return to the Study Centre 14 days following the screening visit and volunteers who comply with all the inclusion and exclusion criteria will be randomly allocated to one of three treatment groups at the baseline visit. Two of the groups will receive one of two probiotics containing either Lactobacillus (A) or Lactobacillus (B). The third group will receive placebo (P) which does not contain any active ingredient. Each subject will receive a fluoride toothpaste (Colgate Regular) and toothbrush (Oral-B) at the pre-baseline visit to reduce any carry-over (anti-microbial) effects from their normal toothpaste usage.
The initial brushing with the gum shield in place will be conducted under supervision by the study staff at the study centre to enable participants to be familiar with using the gum shield during their unsupervised brushing at home. Each participant will be given both verbal and written instructions, to enable them to correctly insert the gum shield under supervision; the placement of the gum shield will be checked by a study staff member, followed by supervised brushing of the upper teeth.
At the baseline visit those participants who fulfil the inclusion/exclusion criteria will receive a fluoride toothpaste (Colgate Regular) and toothbrush (Oral-B) for use throughout the duration of the study. All treatments will be unsupervised at the subject's home. Participants will be provided with a participant diary at the screening visit to check for compliance with tooth brushing throughout the study period. At the baseline visit those volunteers who successfully completed the inclusion/exclusion criteria will continue to complete the participant diary for compliance with twice daily tooth brushing, the test and control products and the placement of the gum shield over the lower teeth when brushing the upper teeth during the study. Those participants who fail to satisfy the inclusion/exclusion criteria will return the diary together with the fluoride toothpaste and toothbrush at the baseline visit.
Participants will be instructed to abstain from all methods of tooth cleaning in the lower (mandible) jaw for two weeks apart from the fluoride toothpaste provided by the study centre. A soft acrylic stent (gum shield) will be fabricated to cover the teeth in the lower jaw (mandible) whilst brushing the teeth in the upper (maxilla) jaw and will be removed 10 minutes after brushing. The soft stent can be easily inserted and removed without disturbance of the developing plaque whilst ensuring participants do not brush their lower teeth and thus disrupt plaque formation. Modified Gingival Index (MGI) (Lobene et al. 1986) assessments will be undertaken prior to the other assessments as this is non-invasive assessment. At baseline and after two weeks (+ 14 days) four sites/tooth (mesial, mid-buccal, distal and lingual) will be probed using the Gingival Bleeding Index [GBI]) as defined by Saxton \& van der Ouderaa (1989) to assess the health status of the gingiva. Probing following one week of plaque accumulation will be avoided as bleeding in the gingival crevice may influence the developing biofilm. Non-invasive samples of gingival crevicular fluid (GCF) will however, be collected at all-time intervals before the BOP measurements or plaque sampling as the volume of GCF (Kistler et al. 2013) has been shown to increase before the development of clinically evident inflammation e.g. GBI. The GCF samples will be collected from the mesio-buccal sites of 4 selected sites (two teeth in each quadrant of the lower [mandible] jaw) on perio strips (ProFlow Inc. Amityville, NY) (Thunell et al. 2010). The strip will be applied in the gingival sulcus for 30 seconds to collect a standardised GCF fluid sample. The GCF samples will be pooled from 4 sites of each participant as indicated above at each time point and analysed on an individual basis. The number of sites with clearly visible plaque following the disclosing of the teeth in the lower (mandible) jaw (modified Quigley-Hein) (Turesky et al. 1970) will be recorded. Plaque will be collected from the buccal and lingual surfaces of teeth in the lower (mandible) jaw excluding 3rd molars from each participant using a sterile curette and placed in tubes with saturated saline-DMSO buffer. The plaque samples, and GCF samples in tubes with Phosphate Buffered Saline (PBS), will be transported on dry ice and stored at -80°C. All assessments and sample collection will be undertaken by trained and calibrated personnel. After two weeks, all participants who complete the study will receive a dental prophylaxis following the collection of samples and will be asked to resume their normal oral hygiene regime.
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.
Exclusion Criteria:
Any disease which in the investigator's opinion could affect the participant's response to treatment, including in particular:
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.
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
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
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
Lozenges for Home use
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to +14 days
Changes in Inflammatory Markers
To assess changes in inflammatory markers in Gingival Crevicular Fluid following use of each test product
Time frame: Baseline to + 14 days
Changes in Bacterial Composition
To assess changes in bacterial composition in collected plaque samples following use of each test product
Time frame: Baseline to + 14 days
No study locations are listed for this record.
Plan to share: No
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This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Queen Mary University of London