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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576610
• Other study ID #: HUSMalaysia
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2023
• Source: Hospital Universiti Sains Malaysia
• Contact: Dr Ashwini M Madawana, BDS
• Phone: +60126866033
• Email: drashwini.m[@]student.usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An interventional study will be 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 will be comparing 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Plaque Induced Gingivitis

Intervention

Procedure:
• Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)
The following are advice that will be given face-to-face to parent and participant and a take home pamphlet would be 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.
• Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )
The following are advice that will be given face-to-face to parent and participant and a take home pamphlet would be 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.

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Saliva Bacterial Count	The saliva sample would be collected from 3 patients each of both case control and study groups before and after the intervention. Saliva samples will be collected at the start of the study that is during the delivery of the short dental hygiene educational message, and after 4 weeks. On the day of the saliva sampling, each child will be prohibited from brushing their teeth in the morning and from eating or drinking anything (except water) for at least 2 hours before the saliva sampling time. Every sample will be aspirated by syringe to obtain 1-2 ml as total volume and the saliva sample will be placed in a tube containing the carrier solution.	4 weeks
Primary	Plaque Score	would be measured using the Silness-Loe Plaque Index 1964 from each patient before and after the intervention in both control and case study groups and the mean score and standard deviation would be recorded in a table.; Scoring Criteria 0 No plaque; A film of plaque adhering to the free gingival margin and adjacent area of the tooth.; Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface.; Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.; PIaque Score formula: Total scores / No of teeth examined; Range of scores : Excellent : 0 Good : 0.1-0.9 Fair: 1.0-1.9 Poor: 2.0-3.0	4 weeks
Secondary	Gingivitis Score	would be measured using the Loe and Silness Gingival Index 1963 from each patient before and after the intervention in both control and case study groups and the mean score and standard deviation would be recorded in a table.; Scoring Criteria 0 No inflammation.; Mild inflammation, slight change in color, slight edema, no bleeding on probing.; Moderate inflammation, moderate glazing, redness, bleeding on probing.; Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.; Gingivitis score for the individual would be calculated using a formula as follows : Sum of indices of teeth / no of teeth examined; These scores would be then classified into either a Mild , Moderate or Severe form of Gingivitis as follows : Mild gingivitis : 0.1-1.0 Moderate gingivitis : 1.1-2.0 Severe gingivitis : 2.1-3.0	4 weeks