Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride

Study Overview
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Brief Summary
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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.

Official Title
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Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Inactive supplement
* Drug: Tricalcium phosphate supplement
* Drug: Calcium carbonate supplement
* Drug: Calcium citrate supplement
* Drug: Inactive supplement and fluoride mouthwash
* Drug: Calcium carbonate supplement and fluoride mouthwash
* Drug: Calcium citrate supplement and fluoride mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing calcium supplements<br>Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions. Participants were randomized to determine the sequence of exposure to the different treatments. | Drug: Inactive supplement<br>* Chewable candy (negative control), chewed for 30 seconds.<br>Drug: Tricalcium phosphate supplement<br>* Chewable tricalcium phosphate supplement, chewed for 30 seconds.<br>Drug: Calcium carbonate supplement<br>* Chewable calcium carbonate supplement, chewed for 30 seconds.<br>Drug: Calcium citrate supplement<br>* Chewable calcium citrate supplement, chewed for 30 seconds.<br>|
| Experimental: Fluoride rinse<br>Participants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement. | Drug: Inactive supplement and fluoride mouthwash<br>* 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).<br>Drug: Calcium carbonate supplement and fluoride mouthwash<br>* 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).<br>Drug: Calcium citrate supplement and fluoride mouthwash<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium concentration in saliva at 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. | Baseline | 
| Calcium concentration in the mixture of saliva and chewed 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. | Immediately after the 30-second chewing of calcium supplement | 
| Calcium concentration in saliva at 15 seconds | Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 15 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 30 seconds | Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 30 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 45 seconds | Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 45 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 60 seconds | Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 60 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 120 seconds | Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 120 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 180 seconds | Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 180 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 240 seconds | Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 240 seconds after chewing calcium supplement | 
| Calcium concentration in saliva at 300 seconds | Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method. | 300 seconds after chewing calcium supplement | 
| Area under the curve of calcium concentration in saliva | 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). | Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements | 
| Fluoride concentration in saliva at 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. | Baseline | 
| Fluoride concentration in saliva at time 0 | 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. | 0 minutes after chewing supplement/mouthwashing | 
| Fluoride concentration in saliva at 5 min | 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. | 5 minutes after chewing supplement/mouthwashing | 
| Fluoride concentration in saliva at 15 min | 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. | 15 minutes after chewing supplement/mouthwashing | 
| Fluoride concentration in saliva at 30 min | 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. | 30 minutes after chewing supplement/mouthwashing | 
| Fluoride concentration in saliva at 60 min | 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. | 60 minutes after chewing supplement/mouthwashing | 
| Fluoride concentration in saliva at 120 min | 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. | 120 minutes after chewing supplement/mouthwashing | 
| Area under the curve of fluoride concentration in saliva | 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). | Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing |