Trial Outcomes & Findings for Effects of Probiotics on Oral Health (NCT NCT02444182)

Results Overview

The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered. The criteria are: 0 = no inflammation 1. = mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation, moderate glazing, redness, bleeding on probing 3. = severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four. The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

108 participants

Primary outcome timeframe

Four weeks

Results posted on

2016-03-14

Participant Flow

Inclusion criteria of the study: * healthy subject with no history of systemic antibiotics or topical fluoride treatments within the 4 weeks prior to baseline * subject who agrees to suck lozenges containing probiotics twice a day. * subject who agrees to stop taking any other probiotic containing products during the study period

Participant milestones

Participant milestones
Measure	Probiotics participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted	Control - No Probiotics Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece) Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted
Overall Study STARTED	54	54
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Probiotics participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted	Control - No Probiotics Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece) Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted
Overall Study non-compliance	2	1
Overall Study Lost to Follow-up	0	4

Baseline Characteristics

Effects of Probiotics on Oral Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Probiotics n=54 Participants participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted	Control - No Probiotics n=54 Participants Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece) Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted	Total n=108 Participants Total of all reporting groups
Age, Continuous	14 years STANDARD_DEVIATION 1 • n=5 Participants	14 years STANDARD_DEVIATION 1 • n=7 Participants	14 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Kuwait	54 participants n=5 Participants	54 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks

The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered. The criteria are: 0 = no inflammation 1. = mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation, moderate glazing, redness, bleeding on probing 3. = severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four. The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation

Outcome measures

Outcome measures
Measure	Probiotics n=52 Participants participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted	Control - No Probiotics n=49 Participants Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece) Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted
Gingival Health	0.46 units on a scale Standard Deviation 0.6	0.18 units on a scale Standard Deviation 0.39

PRIMARY outcome

Timeframe: four weeks

A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque 1. = separate flecks of plaque at the cervical margin of the tooth 2. = a thin continuous band of plaque at the cervical margin 3. = a band of plaque wider than 1 mm but covering less than 1/3 of the crown 4. = plaque covering at least 1/3 but less than 2/3 of the crown 5. = plaque covering 2/3 or more of crown An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined. \*\* Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)

Outcome measures

Outcome measures
Measure	Probiotics n=52 Participants participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted	Control - No Probiotics n=49 Participants Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece) Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted
Plaque Index	0.80 units on a scale Standard Deviation 0.76	0.71 units on a scale Standard Deviation 0.67

Adverse Events

Probiotics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - No Probiotics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Abrar Alanzi

Kuwait University - Faculty of Dentistry

Phone: 24636812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place