The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients
Primary Purpose
Gingivitis, Plaque Induced Gingivitis
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)
Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis
Eligibility Criteria
Inclusion Criteria:
- Children of age group 4-7
Exclusion Criteria:
- Children with medical problems
- Children with Special Needs
- Uncooperative Children
Sites / Locations
- Hospital Universiti Sains MalaysiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Enzyme containing mouth spray + Standard Preventive Advice
Normal Saline mouth spray +Standard Preventive Advice
Arm Description
Usage of Oral7 mouth spray along side with the Standard Preventive Advice
Usage of normal saline containing mouth spray along side with the Standard Preventive Advice
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05576610
First Posted
October 3, 2022
Last Updated
September 25, 2023
Sponsor
Hospital Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05576610
Brief Title
The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universiti Sains Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 .
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
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque Induced Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enzyme containing mouth spray + Standard Preventive Advice
Arm Type
Experimental
Arm Description
Usage of Oral7 mouth spray along side with the Standard Preventive Advice
Arm Title
Normal Saline mouth spray +Standard Preventive Advice
Arm Type
Placebo Comparator
Arm Description
Usage of normal saline containing mouth spray along side with the Standard Preventive Advice
Intervention Type
Procedure
Intervention Name(s)
Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)
Other Intervention Name(s)
Oral7 mouth spray
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )
Other Intervention Name(s)
Normal Saline Mouth Spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque Score
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Gingivitis Score
Description
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
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Saliva Bacterial Count
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
_ _ Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
_ Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but not pronounced (sullen, withdrawn).
+ 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.
++ Definitely positive. Good rapport with the dentist, interest in the dental procedures, laughter and enjoyment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Ashwini M Madawana, BDS
Phone
+60126866033
Email
drashwini.m@student.usm.my
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Fadzlinda Baharin, MClinDent(Paeds)
Phone
+6097675995
Email
lindabaharin@usm.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ashwini M.Madawana, BDS
Organizational Affiliation
Hospital Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashwini M.Madawana
Phone
+60126866033
Email
nairm794@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashwini M.Madawana
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant data would be protected under the Ethical Board of Hospital University Sains Malaysia .
Learn more about this trial
The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients
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