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

NCT04199897 | Completed DMC

• 1 other identifier: UCPH_OI_004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Gingivitis

Keywords

Dental Caries; Salivary microbiota; Probiotics

Outcome Measures

Primary Outcomes (1)

• Change in microbial diversity of salivary microbiota

  alpha-diversity (shannon-index)

  Baseline alpha-diversity vs. alpha-diversity at day 35

Secondary Outcomes (2)

• 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

Study Arms (4)

Intervention group (sucrose + probiotics)

EXPERIMENTAL

Sucrose rinsing 8 times a day for 14 days Probiotic lozenges 2 times a day for 25 days

Dietary Supplement: Succrose rinsing; Dietary Supplement: Probiotic lozenges

Intervention group (sucrose + placebo

ACTIVE COMPARATOR

Sucrose rinsing 8 times a day for 14 days Placebo lozenges 2 times a day for 25 days

Dietary Supplement: Succrose rinsing; Other: Placebo tablets

Control group (xylitol + probiotics)

PLACEBO COMPARATOR

Xylitol rinsing 8 times a day for 14 days Probiotic lozenges 2 times a day for 25 days

Dietary Supplement: Probiotic lozenges; Other: xylitol rinsing

Control group (xylitol + placebo

PLACEBO COMPARATOR

Xylitol rinsing 8 times a day for 14 days Placebo lozenges 2 times a day for 25 days

Other: xylitol rinsing; Other: Placebo tablets

Interventions

Succrose rinsing DIETARY_SUPPLEMENT

Sucrose rinsing 7-8 times a day for 14 days

Intervention group (sucrose + placebo; Intervention group (sucrose + probiotics)

Probiotic lozenges DIETARY_SUPPLEMENT

Probiotic lozenges 2 times a day for 35 days

Control group (xylitol + probiotics); Intervention group (sucrose + probiotics)

xylitol rinsing OTHER

Xylitol rinsing 7-8 times a day for 14 days

Control group (xylitol + placebo; Control group (xylitol + probiotics)

Placebo tablets OTHER

Placebo lozenges 2 times a day for 35 days

Control group (xylitol + placebo; Intervention group (sucrose + placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• more than 20 own natural teeth
• no chronic systemic diseases affecting salivary functions
• no medication except for contraceptives
• non-smoker

You may not qualify if:

• treatment requiring oral diseases i.e. dental caries, gingivitis and periodontitis
• systemic antibiotics within the latest 3 months

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen, Dept. of Odontology

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Dental Caries; Gingivitis

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computerized randomization followed by pseudo anonymication
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Principal Investiator, dr. odont., PhD, DDS

Model Details: The study will employ a randomized triple-blind, placebo controlled design.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 16, 2019
• Study Start: May 5, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)