Effect of a 2-week Sugar Stress on Bacterial Profiles in Whole Saliva

NCT04199897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-10-15

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Gingivitis

Interventions

DIETARY_SUPPLEMENT

Succrose rinsing

Sucrose rinsing 7-8 times a day for 14 days

DIETARY_SUPPLEMENT

Probiotic lozenges

Probiotic lozenges 2 times a day for 35 days

OTHER

xylitol rinsing

Xylitol rinsing 7-8 times a day for 14 days

OTHER

Placebo tablets

Placebo lozenges 2 times a day for 35 days

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199897 on ClinicalTrials.gov