Clinical trial NCT04620252: Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride
Official title: Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dental Caries
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Reported good general health
* Reported good oral health
* Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
* Having normal salivary flow rate according to direct flow rate determination methods
* Agreement to adhere to the study protocol

Exclusion Criteria:

* Unable to understand and/or follow study instructions
* Hyposalivation
* Active periodontitis, identified by frequent bleeding of the gums
* Oral pain
* In need of urgent dental care

Primary outcomes:
measure: Calcium concentration in saliva at baseline
timeFrame: Baseline
measure: Calcium concentration in the mixture of saliva and chewed calcium supplement
timeFrame: Immediately after the 30-second chewing of calcium supplement
measure: Calcium concentration in saliva at 15 seconds
timeFrame: 15 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 30 seconds
timeFrame: 30 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 45 seconds
timeFrame: 45 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 60 seconds
timeFrame: 60 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 120 seconds
timeFrame: 120 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 180 seconds
timeFrame: 180 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 240 seconds
timeFrame: 240 seconds after chewing calcium supplement
measure: Calcium concentration in saliva at 300 seconds
timeFrame: 300 seconds after chewing calcium supplement
measure: Area under the curve of calcium concentration in saliva
timeFrame: Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements
measure: Fluoride concentration in saliva at baseline
timeFrame: Baseline
measure: Fluoride concentration in saliva at time 0
timeFrame: 0 minutes after chewing supplement/mouthwashing
measure: Fluoride concentration in saliva at 5 min
timeFrame: 5 minutes after chewing supplement/mouthwashing
measure: Fluoride concentration in saliva at 15 min
timeFrame: 15 minutes after chewing supplement/mouthwashing
measure: Fluoride concentration in saliva at 30 min
timeFrame: 30 minutes after chewing supplement/mouthwashing
measure: Fluoride concentration in saliva at 60 min
timeFrame: 60 minutes after chewing supplement/mouthwashing
measure: Fluoride concentration in saliva at 120 min
timeFrame: 120 minutes after chewing supplement/mouthwashing
measure: Area under the curve of fluoride concentration in saliva
timeFrame: Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: School of Dentistry, University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor, University of Michigan
name: Livia M Tenuta, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: