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CTRI Number  CTRI/2025/08/092190 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 19/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Comparative Evaluation of the Levels of Salivary Calcium and Phosphorus following the application of Embrace and Enamelast Varnish  
Scientific Title of Study   A Comparative Evaluation of the levels of Salivary Calcium and Phosphorus following the application of Embrace versus Enamelast Varnish  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjari P 
Designation  Post graduate 
Affiliation  VINAYAKA MISSION DENTAL COLLEGE 
Address  Room No 6 Department of Pediatric and Preventive dentistry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem.636308

Salem
TAMIL NADU
636308
India 
Phone  63811347019  
Fax    
Email  manjupandian2211@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena Arali 
Designation  Professor and HOD 
Affiliation  VINAYAKA MISSION DENTAL COLLEGE 
Address  Room No 6 Department of Pediatric and Preventive dentidtry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem.

Salem
TAMIL NADU
636308
India 
Phone  8344545722  
Fax    
Email  muthusri.b@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjari P 
Designation  Post graduate 
Affiliation  VINAYAKA MISSION DENTAL COLLEGE 
Address  Room No 6 Department of Pediatric and Preventive Dentistry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem.636308

Salem
TAMIL NADU
636308
India 
Phone  6381347019  
Fax    
Email  manjupandian2211@gmail.com  
 
Source of Monetary or Material Support  
Room No 6 Department of Pediatric and Preventive Dentistry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem. 636308 
 
Primary Sponsor  
Name  Dr Manjari P 
Address  Room No 6 Department of Pediatric and Preventive Dentistry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjari P  Vinayaka Missions Sankarachariyar Dental College  Room No 6 Department of Pediatric and Preventive Dentistry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308
Salem
TAMIL NADU 
6381347019

manjupandian2211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF VMS DENTAL COLLEGE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  APPLICATION OF FLUORIDE VARNISH  APPLICATION OF 5 PERCENT EMBRACE FLUORIDE VARNISH WITH BRUSH ON BUCCAL LINGUAL AND OCCLUSAL SURFACE 
Comparator Agent  APPLICATION OF FLUORIDE VARNISH   APPLICATION OF 5 PERCENT ENAMELAST FLUORIDE VARNISH WITH BRUSH ON BUCCAL,LINGUAL AND OCCLUSAL SURFACE ON ALL TEETH  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  Children who are uncooperative
Children with DMFT/deft score GREATER THAN 8
Caries involving Pulp
Children with unwilling parents
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
IDENTIFY WHICH FLUORIDE VARNISH RELEASE MORE CALCIUM AND PHOSPHORUS AT 1 MONTH AND 3 MONTH  IDENTIFY WHICH FLUROIDE VARNISH RELEASE MORE CALCIUM AND PHOSPHORUS AT 1 MONTH AND 3 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/08/2025 
Date of Study Completion (India) 22/01/2026 
Date of First Enrollment (Global)  10/08/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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: 50 Children - 25 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: 6 months

Study population

A total of 50 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 at 1 month and 3 month following the first 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.

 
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