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

NCT05576610 | Completed

• 1 other identifier: HUSMalaysia
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 .

Conditions

Gingivitis; Plaque Induced Gingivitis

Outcome Measures

Primary Outcomes (1)

• Plaque Score

  Was 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 was recorded in a table. Scoring Criteria 0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface. 3. 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 Outcomes (1)

• Gingivitis Score

  4 weeks

Other Outcomes (1)

• Saliva Bacterial Count

  4 weeks

Study Arms (2)

Enzyme containing mouth spray + Standard Preventive Advice

EXPERIMENTAL

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

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

Normal Saline mouth spray +Standard Preventive Advice

PLACEBO COMPARATOR

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

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

Interventions

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

Also known as: Oral7 mouth spray

Enzyme containing mouth spray + Standard Preventive Advice

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

Also known as: Normal Saline Mouth Spray

Normal Saline mouth spray +Standard Preventive Advice

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children of age group 4-7

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dr Ashwini M.Madawana, BDS

  Hospital Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 12, 2022
• Study Start: July 31, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 31, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)