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

NCT ID: NCT05576610

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Enzyme containing mouth spray + Standard Preventive Advice

Usage of Oral7 mouth spray along side with the Standard Preventive Advice

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Normal Saline mouth spray +Standard Preventive Advice

Usage of normal saline containing mouth spray along side with the Standard Preventive Advice

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Oral7 mouth spray; Normal Saline Mouth Spray

Eligibility Criteria

Inclusion Criteria

• Children of age group 4-7

Exclusion Criteria

• Children with medical problems
• Children with Special Needs
• Uncooperative Children ( Level of Cooperation would be measured using Frankl's behavior scale)

Reviewer's comment : To list down Frankl's Classification and how we define uncooperative

As per AAPD 2022 , The Frankl behavior rating scale is a frequently used behavior rating systems in both clinical dentistry and research. This scale indicates observed child's behaviors into four categories (1; Definitely negative, 2; Negative, 3; Positive, 4; Definitely positive)

1. _ _ Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.

2. _ Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but not pronounced (sullen, withdrawn).

3. + Positive. Acceptance of treatmen, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.

4. ++ Definitely positive. Good rapport with the dentist, interest in the dental procedures, laughter and enjoyment

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Ashwini M. Madawana

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Ashwini M.Madawana, BDS

Role: PRINCIPAL_INVESTIGATOR

Hospital Universiti Sains Malaysia

Locations

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Countries

Malaysia

Other Identifiers

HUSMalaysia

Identifier Type: -

Identifier Source: org_study_id