Effects of Probiotics on Oral Health

NCT02444182 | Completed Phase 1 Results

• 1 other identifier: DD04/13
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Some probiotics have been shown to have preventive effects on infectious diseases and allergies. Because their long-term enhancement of the immune responses of children, they have been recommended for infants in some countries. The most promising ones seem to be the combination of Bifidobacterium lactis BB-12 and Lactobacillus rhamnosus GG. Probiotic microbes are mainly ingested orally and the gastrointestinal tract is thus the primary target organ for them. However, the mouth is the first part of the gastrointestinal tract. Most probiotics are in theory cariogenic, thus their effects on oral health should be known. Several probiotics decrease levels of salivary mutans streptococci (MS), but in other respects very little is known about their effects on the oral microbiota. Also effects of probiotics on dental plaque should be studied. This study aims to find out the effects of the combination of BB-12 and LGG, delivered with a lozenge (4 weeks, twice a day) with a mixture of them on the amount of plaque and gingival health

Conditions

Periodontal Health; Dental Plaque Accumulation

Outcome Measures

Primary Outcomes (2)

• Gingival Health

  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

  Four weeks

• Plaque Index

  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)

  four weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

participants will receive a lozenge containing mixture of probiotic bacteria BB-12 and LGG

Dietary Supplement: Probiotics

Control - No probiotics

PLACEBO COMPARATOR

Participants will receive a control lozenge containing no probiotics. all lozenges are sugar-free; sweetened by xylitol (0.5 g xylitol per piece)

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

A half of the participants will be randomly allocated to the probiotics group. They will receive a probiotics lozenge twice a day for 4 weeks. Pre and Post intervention clinical exam will be conducted

Probiotics

Placebo DIETARY_SUPPLEMENT

A half of the participants will be randomly allocated to the placebo group. Lozenges with no probiotics will be given twice daily for 4 weeks. Pre and Post intervention clinical exam will be conducted

Control - No probiotics

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Adolescent - ASA I \& II
• No Antibiotics use
• No intake of commercially available probiotics products during the intervention

You may not qualify if:

• Adolescents have ASA III or IV
• Antibiotics use
• refuse to stop taking commercially available probiotics products during intervention

Sponsors & Collaborators

• Kuwait University: lead
• University of Turku: collaborator

Study Sites (1)

Abdullah Alwaheeb intermediate School

Kuwait City, Kuwait, 13110, Kuwait

Location

Related Publications (1)

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 RESULT

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

limitations of this study include: 1. short period: only 4 weeks to reach maximum compliance 2. number of participants: just above the minimum sample size due to refusal of many parents to give consent for their children participation.

Results Point of Contact

• Title: Dr. Abrar Alanzi
• Organization: Kuwait University - Faculty of Dentistry

aalanzi@hsc.edu.kw

24636812

Study Officials

• ABRAR N ALANZI, MS

  KUWAIT UNIVERISTY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

KU (1)