Comparative Evaluation of Two Remineralizing Agents on Salivary pH and Salivary Flow Rate – An in vivo study

Need for the study

Caries is defined as a process of enamel or dentin dissolution that is caused by microbial action at the tooth surface and is mediated by physiochemical flow of water dissolved ions(Ostrom, 1980). Saliva is a heterogenous liquid mainly composed of water and encompasses organic and inorganic constituents. It functions as a cleaning, lubricating, oral health maintaining and a buffering agent for the teeth and oral mucosa while also serving as a calcium and phosphate storage solution. The ions in the saliva remineralize initial carious lesions.2 Salivary pH and buffering capacity are crucial characteristics in managing the ion exchanges throughout the remineralization and demineralization of enamel. Normal salivary pH ranges from 6.2 to 7.6.2 The Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) complex derived from a milk protein- Casein has been reported to inhibit enamel demineralization by maintaining the supersaturation of calcium and phosphate in saliva, buffering of plaque pH and increasing the calcium and phosphate ion levels in plaque. Toothmin consists of a formula known as Anticay which aids in remineralization. Anticay is a mixture of calcium salts of sucrose phosphate esters, complexed with inorganic calcium phosphate. It is composed of 10-12% calcium and 8-10% phosphorous by weight.4 Thus, the aim of the study is intended to comparatively evaluate the effect of Two Remineralizing Agents : Toothmin and GC Tooth Mousse on Salivary pH and Salivary Flow Rate.

Aim of Study: To evaluate and compare the effect of Two Remineralizing Agents: Toothmin(Abbott) and GC Tooth Mousse on Salivary pH and Salivary Flow Rate.

Objectives of this study:

1. To evaluate the Salivary pH using Toothmin (Abbott) and GC Tooth Mousse.

2. To evaluate the Salivary Flow Rate using Toothmin (Abbott) and GC Tooth Mousse

3. To compare the Salivary pH and Salivary Flow Rate using Toothmin (Abbott) and GC Tooth Mousse.

Source of data

Type of study – Randomized Clinical Trial

In-vitro/in-vivo/survey – In – vivo study

Source from where the cases, patients, subjects, or study material will be selected-

Patient reporting on OPD as well as patients from organized school dental camps by the Dept of Pediatric and Preventive Dentistry, Dr. D.Y Patil Dental College and Hospital, Pimpri, Pune.

Name and place where the study will be conducted- Dept of Pediatric and Preventive Dentistry, Dr. D. Y Patil Dental College and Hospital, Pimpri, Pune.

Method of data collection

Sampling technique used – Simple Random Sampling

Sample size – 40

Size of each group: 20

Group I: Toothmin

Group II: GC Tooth Mousse

Inclusion criteria: 1. Children 6-9 years of age. 2. Participants should not have any dental caries (code 0 according to ICDAS-II). 3. Participants parents who give consent to participate in the study.

Exclusion criteria: 1. Any systemic disease that affect flow rate of saliva. 2. Patients undergoing orthodontic treatment. 3. Patients taking any antibiotics or any kind of medications past 1 month that can affect the salivary flow rate. 4. Patients having confirmed or suspected allergy to proteins. 5. Patients with special health care needs, calcium or phosphate deficiency.

MATERIALS:

Calcium Sucrose Phosphate (Toothmin, Abbott)

Casein Phosphopeptide-Amorphous Calcium Phosphate (GC Tooth Mousse)

Paraffin wax

INSTRUMENTS:

Diagnostic instruments

Graduated test tubes

pH meter, calibration done with buffer powder as per manufacturing instructions (IONIX)

ARMAMENTERIUM:

Mouth mask, Head cap

Gloves

Procedure:

Patients will be selected according to the inclusion and exclusion criteria. The study procedure will be explained to each participant’s parents and necessary informed consent from the parent/guardian and assent from the child will be obtained in a language that they understand. Patients will be divided into two groups randomly by computer generated random numbers.

Group 1: Tooth Mousse N = 20    Group 2: GC Toothmin N = 20

Patients will be asked not to eat or drink anything for 2 hours before collecting salivary sample. Salivary samples will be collected from the patients between 10am-12pm. Children will be given sugar-free gums to chew for a period of 3 minutes under operator’s supervision and later drooled saliva will be collected into saliva collecting tube. Toothmin (Abbott) and GC Tooth Mousse will be applied after salivary sample collection.

The salivary sample collection process will be done 4 times: before the application of the agents to be studied(T0), immediately after the application of the agents(T1), after half an hour(T2) and after an hour(T3). pH of the saliva will be measured in each point of time using calibrated pH meter. The amount of saliva collected will be calculated and divided by 3 to report the amount of saliva collected per minute(ml/min). Data will be recorded and tabulated and results will be analyzed using statistical analysis method.

Method of data analysis:

Unpaired t- test

Repeated measures ANOVA with post-hoc test