NCT05576610

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hospital Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

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 .

Detailed description

General Objective To evaluate the effect of enzyme-containing mouth sprays on children's oral health compared to those receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up. Specific Objectives 1. To compare the mean plaque score in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up. 2. To compare the mean gingivitis score in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up. 3. To compare the mean saliva bacterial count in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.

Conditions

• Gingivitis
• Plaque Induced Gingivitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-01-01
• Completion: 2024-01-31
• First posted: 2022-10-12
• Last updated: 2024-06-11

Locations

1 site across 1 country: Malaysia