CTRI

Dental caries is an infectious and microbiological disease that results in localized dissolution and destruction of the calcified tissues of the tooth. Caries process begins with enamel dissolution when pH drops below 5.5 causing increased demineralization rate.

Fluoride varnish is the most acceptable fluoride delivery vehicle due to the extended time of contact on tooth surfaces and thereby avoids the direct loss of fluoride after application. An acceptable amount of calcium and phosphate ions in the topical fluoride has an essential role in caries prevention.

In recent years, the addition of new substances to fluoride varnishes aimed to gain the advantages of increasing their anticaries and remineralization potential.

Embrace varnish is a new fluoride varnish which contains xylitol-coated calcium and phosphate which is said to prevent calcium and phosphate salts from reacting until they encounter saliva. The saliva dissolves the xylitol and releases the calcium and phosphate ions, forming protective fluorapatite when reacting with the fluoride ions in saliva.

Enamelast fluoride varnish is a xylitol-sweetened, 5 percent sodium fluoride in a resin carrier. Enamelast fluoride varnish promotes enhanced and sustained fluoride release. It’s superior fluoride release and uptake means more fluoride is absorbed into the enamel over a longer period of time.

A literature search found that no comparative studies have been conducted on the in vivo remineralization effect of these varnishes. The aim of this study to evaluate and compare the salivary components after application of Embrace varnish and Enamelast varnish.

Hypothesis: There will be no change in the levels of Salivary Calcium and Phosphorus following application of the varnishes.
METHOD:
Sample size: 30 Children - 15 per group. Following are calculated as per the key article.

Source of study: Children coming to the Department of Pediatric and Preventive Dentistry, VMSDC, Salem.

Duration: 1 week

Study population

A total of 30 children between 6 to 10 years will be included in this study. The children will be divided into two groups. Group I consist of children who will be treated with embrace varnish and Group II consist of children who will be treated with Enamelast varnish.

Inclusion criteria

6 to 10 year old children in mixed dentition stage.

Children who are cooperative

Children with DMFT deft score less than 8

Caries involving Enamel and Dentin

Exclusion Criteria

Children who are uncooperative

Children with DMFT deft score 8

Caries involving Pulp

Children with unwilling parents

Methodology

All participants will be instructed not to eat or drink at least one hour prior to the collection of saliva. Saliva will be collected between 9 and 12 AM.

Prior to the collection of saliva, subjects will be asked to rinse their mouth with water and then wait for 1 to 2 min for water clearance. Unstimulated whole saliva will be collected by making the subjects sit in an upright position with their heads slightly inclined. The passively drooled saliva collected in the floor of mouth will be expectorated into graduated saliva-collecting vials. Three millilitres of unstimulated whole saliva will be collected.

The baseline sample of both groups will be collected first following which, the groups will receive their respective varnish application.

Embrace varnish and Enamelast varnish will be applied on all the teeth including the buccal, occlusal, lingual surfaces of all the teeth of their respective groups. Saliva samples will be collected after 1 week following the application.

The salivary samples will be stored in a chiller box containing ice packs and transported to the lab.

Laboratory analysis

Estimation of Salivary Calcium and Phosphorous

Calcium will be measured colorimetrically using Arsenazo Dye III which will measure the element spectrophotometrically at a wavelength of 680 nm.

Phosphorous reacts with ammonium molybdate to form ammonium phosphomolybdate, which will measure the element spectrophotometrically at a wavelength of 670 nm.

https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=136443&EncHid=14190.17