Dental Caries, Dental Plaque
Conditions
Keywords
Biofilm, Sugar, xylitol, erythritol
Brief summary
This study will assess the effectiveness of erythritol and xylitol in suppressing biofilm activity, using both within-subject and between-group comparisons.
Detailed description
Xylitol and erythritol are sugar alcohols that cariogenic bacteria cannot readily ferment. Most clinical evidence comes from chewing gum; few studies have tested polyol mints in people, and none has compared xylitol and erythritol mints with a real-time measure of plaque activity. This is a single-center, randomized (1:1), parallel-group, examiner-blinded trial in 80 healthy adults at Loma Linda University School of Dentistry. The randomization sequence is generated in jamovi. The xylitol group takes two Epic Xylitol mints (about 0.25 g xylitol each) twice daily; the erythritol group takes one DC24 Daily Care erythritol mint (about 0.5 g erythritol) twice daily. Both groups receive about 1 g of polyol per day for 7 days. Participants arrive in the morning without brushing or eating. A trained, calibrated examiner who does not know the group assignment swabs the lingual surfaces of the lower anterior teeth for about 5 seconds, and the CariScreen meter reports a reading from 0 to 9,999 within about 15 seconds. A different, unblinded team member handles randomization and dispenses the mints. Measurements are taken at Visit 1 (baseline) and Visit 2 (after one week). Participants avoid other sugar-alcohol products during the study week. Adverse events are reviewed at Visit 2.
Interventions
DIETARY_SUPPLEMENTXylitol
Participants will consume two Epic Xylitol mints (\~0.25 g xylitol each) twice daily for one week
DIETARY_SUPPLEMENTErythritol
Participants will consume one DC24 erythritol mint (\~0.5 g erythritol) twice daily for one week
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The examiner who collects plaque samples and records CariScreen readings does not know group assignment. A separate, unblinded team member randomizes participants and dispenses mints.
Intervention model description
Participants are randomized 1:1 to xylitol mints or erythritol mints for one week.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects are 18 years or older; * Subjects who will comply with study protocol; * Subjects who can read and understand the consent form; * Subjects available during the study period; * Subjects have 20 or more natural teeth.
Exclusion criteria
* Allergy or intolerance to study product ingredients; * Systemic antibiotic use within the preceding 30 days; * Active oral infections; * History of systemic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biofilm Metabolic Activity Assessment with Xylitol | Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline) | Plaque from the lingual surfaces of the lower anterior teeth is swabbed and read immediately with the CariScreen ATP meter (relative light units, 0-9,999; higher = more bacterial metabolic activity). Change = 1 week post-baseline minus baseline, reported within each arm. |
| Biofilm Metabolic Activity Assessment with Erythritol | Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline) | Plaque from the lingual surfaces of the lower anterior teeth is swabbed and read immediately with the CariScreen ATP meter (relative light units, 0-9,999; higher = more bacterial metabolic activity). Change = 1 week post-baseline minus baseline, reported within each arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ATP reading by baseline caries risk category | Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline) by risk category (low, moderate, high) | Change from baseline in CariScreen reading, by American Dental Association (ADA) Caries Risk Assessment category (low, moderate, high). |
Contacts
CONTACTSo Ran Kwon, DDS, MS, PhD
PRINCIPAL_INVESTIGATORSo Ran Kwon, DDS, MS, PhD
Loma Linda University
Outcome results
None listed