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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 .
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzyme containing mouth spray + Standard Preventive Advice | Experimental | Usage of Oral7 mouth spray along side with the Standard Preventive Advice |
|
| Normal Saline mouth spray +Standard Preventive Advice | Placebo Comparator | Usage of normal saline containing mouth spray along side with the Standard Preventive Advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gingivitis Score | Was 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.
Gingivitis score for the individual would be calculated using a formula as follows : Sum of indices of teeth / no of teeth examined These scores was 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva Bacterial Count | The saliva sample was collected from 3 patients each of both case control and study groups before and after the intervention. Saliva samples were collected at the start of the study that is during the delivery of the short dental hygiene educational message, and after 4 weeks. Every child involved was then told to spit in a centrifuge tube to obtain 1-2 ml of total volume. The saliva was then cultured in the lab for saliva bacteria analysis. |
Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Dr Ashwini M.Madawana, BDS | Hospital Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150 | Malaysia |
Individual Participant data would be protected under the Ethical Board of Hospital University Sains Malaysia .
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|
|
| 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:
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. |
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|
| 4 weeks |
| 4 weeks |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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