The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients

Summary

An interventional study was done on evaluating the Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans levels in Paediatric Patients attending Hospital Universiti Sains Malaysia ( HUSM ) , Kelantan. This study compared the gingivitis score , plaque score and saliva bacteria count between the patients receiving a standard preventive advice alongside with normal saline mouth spray and those receiving standard preventive advice alongside with an enzyme containing mouth spray .

Conditions

• Gingivitis
• Plaque Induced Gingivitis

Interventions

PROCEDURE

Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)

The following were the advices given face-to-face to parent and participant and a take home pamphlet was provided: * Ensure thorough cleaning especially at the gum line and in the areas between the teeth. * To not share toothbrushes. * To use toothpaste containing fluoride at least 1000ppm fluoride concentration. * To store toothbrushes apart to prevent spread of diseases through the bristles. * To brush teeth at least twice a day, after meals and before bed. * To brush for as long as two to three minutes. * Parents would be advised told to supervise the participant's brushing. Frequency of using the Mouth spray would be two puffs, three times a day that is in the morning after waking up, during tea time and before sleep. A squirt is to be applied to the right/left side of the mouth on the buccal aspect and a squirt on the lingual aspect. Parents will be asked to apply the spray and to supervise children during oral hygiene procedures.

PROCEDURE

Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )

The following were the advices given face-to-face to parent and participant and a take home pamphlet was provided: * Ensure thorough cleaning especially at the gum line and in the areas between the teeth. * To not share toothbrushes. * To use toothpaste containing fluoride at least 1000ppm fluoride concentration. * To store toothbrushes apart to prevent spread of diseases through the bristles. * To brush teeth at least twice a day, after meals and before bed. * To brush for as long as two to three minutes. * Parents would be advised told to supervise the participant's brushing. Frequency of using the mouth spray would be two puffs, three times a day that is in the morning after waking up, during tea time and before sleep. A squirt is to be applied to the right/left side of the mouth on the buccal aspect and a squirt on the lingual aspect. Parents will be asked to apply the spray and to supervise children during oral hygiene procedures.

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia

  lead OTHER

Principal Investigators

• Dr Ashwini M.Madawana, BDS · Hospital Universiti Sains Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-31

Primary Completion

2024-01-01

Completion

2024-01-31

Countries

• Malaysia

Study Locations