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

Hospital Universiti Sains Malaysia

Status: Completed

Conditions: Plaque Induced Gingivitis; Gingivitis

Treatments: Procedure: Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray ); Procedure: Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)

Study type: Interventional

Funder types: Other

Identifiers

NCT05576610

HUSMalaysia

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Enzyme containing mouth spray + Standard Preventive Advice

Experimental group

Description:

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

Treatment:

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

Normal Saline mouth spray +Standard Preventive Advice

Placebo Comparator group

Description:

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

Treatment:

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