Effect of a 2-week Sugar Stress With and Without Probiotic Supplements on Bacterial Profiles in Whole Saliva: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in microbial diversity of salivary microbiota
Study Overview
Brief Summary
Dental caries is a non-communicable biofilm-mediated disease affecting both crown and exposed root surfaces in the primary and permanent dentitions. The carious process involves interactions between the biofilm formed on the tooth surface, sugars, salivary and genetic factors. Based on more than 100 years of research, there is unequivocal evidence that dietary fermentable carbohydrates (sugars and starch) play a key role in caries initiation and progression. In this context, sucrose deserves special attention; apart from being rapidly converted into acids it is also synthesized into extracellular glucans, fructans and intracellular storage compounds. According to the ecological plaque hypothesis, it is generally accepted that sucrose exposure is fueling and driving the stable and diverse symbiotic oral biofilm to a dysbiotic form with a reduced diversity and overgrowth of acidogenic and acid-tolerating species. Such typical bacterial profiles have demonstrated in subjects with different stages of caries in cross-sectional settings but the timing associated with a sugar provocations is less known. Moreover, the use of probiotic bacteria in adjunct to regular oral care to support biofilm diversity and prevent dental caries has gained momentum in recent years. It has been demonstrated that probiotic supplements can increase salivary pH, and reduce the counts of salivary S. mutans, thereby exert a stabilizing effect on the oral microbiota. In this context, it is of interest to explore whether or not the use of beneficial bacteria can counteract a sugar-driven shift in the salivary microbiota. Another question of interest is to study if the oral biofilm has a colonization memory similar to that of the gastro-intestinal tract and the suggested study design could possibly enlighten this area of research.
Detailed Description
Objective
The aim of this study is to investigate the bacterial profiles in whole saliva before and after a 2-week sugar provocation with and without probiotic supplements in healthy young adults. A second aim is to study the bacterial profiles 3 weeks after the termination of the sugar stress. The null hypothesis are:
- Sucrose-induced stress does not affect the bacterial profiles in whole saliva compared with stress induced by a non-fermentable pentitol (xylitol)
- The intake of lactobacilli-derived probiotic bacteria does not affect the sugar-induced changes in the bacterial profiles in whole saliva when compared with placebo
- The bacterial profiles in saliva do not differ from baseline 3 weeks after the termination of the intervention.
Material The study group will consist of 80 young adults with uncompromised oral health that volunteer after informed consent. The inclusion criteria are i) over 18 years with more than 20 own natural teeth, ii) no chronic systemic diseases affecting salivary functions, iii) no medication except for contraceptives, and iv) being a non-smoker. The project will be submitted for ethical approval.
Study design The study will employ a randomized triple-blind, placebo controlled design with four parallel arms as shown in Figure 1. The group allocation will be arranged through computer-generated envelopes and concealed for all parts (subjects, investigators, laboratory staff). After the baseline registration (Day 0), the participants are asked to rinse their mouth with 10 mL of a sucrose- or xylitol-containing solution every second hour (7-8 times per day) during 14 days (day 14). The solution should be "swished" around and between the teeth for at least 30 seconds and then spitted out. No after-rinsing with water is allowed. In addition, the subjects are provided with tablets containing either probiotic lactobacilli or placebo for daily use during the 14-day rinsing period. The participants will be thoroughly instructed to maintain their normal eating and drinking habits as well as their daily oral hygiene procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Computerized randomization followed by pseudo anonymication
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •more than 20 own natural teeth
- •no chronic systemic diseases affecting salivary functions
- •no medication except for contraceptives
- •non-smoker
Exclusion Criteria
- •treatment requiring oral diseases i.e. dental caries, gingivitis and periodontitis
- •systemic antibiotics within the latest 3 months
Arms & Interventions
Control group (xylitol + placebo
Xylitol rinsing 8 times a day for 14 days Placebo lozenges 2 times a day for 25 days
Intervention: xylitol rinsing (Other)
Control group (xylitol + placebo
Xylitol rinsing 8 times a day for 14 days Placebo lozenges 2 times a day for 25 days
Intervention: Placebo tablets (Other)
Intervention group (sucrose + probiotics)
Sucrose rinsing 8 times a day for 14 days Probiotic lozenges 2 times a day for 25 days
Intervention: Succrose rinsing (Dietary Supplement)
Intervention group (sucrose + probiotics)
Sucrose rinsing 8 times a day for 14 days Probiotic lozenges 2 times a day for 25 days
Intervention: Probiotic lozenges (Dietary Supplement)
Intervention group (sucrose + placebo
Sucrose rinsing 8 times a day for 14 days Placebo lozenges 2 times a day for 25 days
Intervention: Succrose rinsing (Dietary Supplement)
Intervention group (sucrose + placebo
Sucrose rinsing 8 times a day for 14 days Placebo lozenges 2 times a day for 25 days
Intervention: Placebo tablets (Other)
Control group (xylitol + probiotics)
Xylitol rinsing 8 times a day for 14 days Probiotic lozenges 2 times a day for 25 days
Intervention: Probiotic lozenges (Dietary Supplement)
Control group (xylitol + probiotics)
Xylitol rinsing 8 times a day for 14 days Probiotic lozenges 2 times a day for 25 days
Intervention: xylitol rinsing (Other)
Outcomes
Primary Outcomes
Change in microbial diversity of salivary microbiota
Time Frame: Baseline alpha-diversity vs. alpha-diversity at day 35
alpha-diversity (shannon-index)
Secondary Outcomes
- Change in supragingival biofilm level(Baseline plaque-index vs. plaque-index day 35)
- Change in gingival bleeding(Baseline bleeding-index vs. bleeding-index day 35)
Investigators
Daniel Belstrøm, DDS, PhD
Associate professor, Principal Investiator, dr. odont., PhD, DDS
University of Copenhagen