Dental Caries
Conditions
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.
Interventions
DRUGInactive supplement
Chewable candy (negative control), chewed for 30 seconds.
DRUGTricalcium phosphate supplement
Chewable tricalcium phosphate supplement, chewed for 30 seconds.
DRUGCalcium carbonate supplement
Chewable calcium carbonate supplement, chewed for 30 seconds.
DRUGCalcium citrate supplement
Chewable calcium citrate supplement, chewed for 30 seconds.
DRUGInactive supplement and fluoride mouthwash
A chewable candy chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
DRUGCalcium carbonate supplement and fluoride mouthwash
A calcium carbonate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
DRUGCalcium citrate supplement and fluoride mouthwash
A calcium citrate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcium concentration in saliva at 120 seconds | 120 seconds after chewing calcium supplement | Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 180 seconds | 180 seconds after chewing calcium supplement | Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at baseline | Baseline | Saliva collected as one spit, immediately before chewing one of the calcium supplements to be tested in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in the mixture of saliva and chewed calcium supplement | Immediately after the 30-second chewing of calcium supplement | Saliva and remnants of the chewed calcium supplement collected at the end of the chewing period (30 seconds) in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 15 seconds | 15 seconds after chewing calcium supplement | Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 30 seconds | 30 seconds after chewing calcium supplement | Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 45 seconds | 45 seconds after chewing calcium supplement | Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 60 seconds | 60 seconds after chewing calcium supplement | Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 240 seconds | 240 seconds after chewing calcium supplement | Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Calcium concentration in saliva at 300 seconds | 300 seconds after chewing calcium supplement | Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. |
| Area under the curve of calcium concentration in saliva | Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements | Calcium concentration in saliva collected at baseline (before chewing the supplements), and 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing the supplements in Arm 1 expressed as the area under the curve of calcium concentration in saliva as a function of time (milimolar x min). |
| Fluoride concentration in saliva at baseline | Baseline | Saliva will be collected for 2 min, immediately before chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode. |
| Fluoride concentration in saliva at time 0 | 0 minutes after chewing supplement/mouthwashing | Saliva and remnants of the fluoride mouth rinse collected at the end of the rinsing period (1 minute) in Arm 2. Fluoride concentration determined using an ion-specific electrode. |
| Fluoride concentration in saliva at 5 min | 5 minutes after chewing supplement/mouthwashing | Saliva will be collected for 2 min, 5 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode. |
| Fluoride concentration in saliva at 15 min | 15 minutes after chewing supplement/mouthwashing | Saliva collected for 2 min, 15 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode. |
| Fluoride concentration in saliva at 30 min | 30 minutes after chewing supplement/mouthwashing | Saliva collected for 2 min, 30 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode. |
| Fluoride concentration in saliva at 60 min | 60 minutes after chewing supplement/mouthwashing | Saliva collected for 2 min, 60 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode. |
| Fluoride concentration in saliva at 120 min | 120 minutes after chewing supplement/mouthwashing | Saliva collected for 2 min, 120 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode. |
| Area under the curve of fluoride concentration in saliva | Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing | Fluoride concentration in saliva collected at baseline (before treatments), and 0, 5, 15, 30, 60 and 120 minutes after chewing the supplements and/or rinsing the fluoride mouthrinse in Arm 2 expressed as the area under the curve of fluoride concentration in saliva as a function of time (micromolar x min). |
Countries
United States
Outcome results
None listed