GingivitisNCT05576610
The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients
A study testing Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray) in people with Gingivitis and Plaque Induced Gingivitis, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque Induced Gingivitis
- What is being tested?
- Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteMalaysia
- Study dates
- 31 Jul 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of age group 4-7
Who cannot join
- 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.
Show all 9Show fewer
- _ 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 Reluctance to accept treatment, uncooperative, some evidence of negative attitude but not pronounced (sullen, withdrawn).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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
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
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 .
Read the 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.
- Conditions
- Gingivitis, Plaque Induced Gingivitis
- Being tested
- Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray), Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)Procedure or surgery
Also called Oral7 mouth spray
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.
Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )Procedure or surgery
Also called Normal Saline Mouth Spray
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.
| Study group | Role | What they receive |
|---|---|---|
| Enzyme containing mouth spray + Standard Preventive Advice | Experimental | Usage of Oral7 mouth spray along side with the Standard Preventive Advice Receives: 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 Receives: Procedure: Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 4 weeks
Secondary outcomes (1)
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.
- 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 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start31 Jul 2023
- Primary completion1 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwini M. Madawana, Hospital Universiti Sains Malaysia
- Investigators
- Dr Ashwini M.Madawana, BDS, Principal investigator, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576610
- Sponsor's protocol ID
- HUSMalaysia
- Status last verified
- Jun 2024
- First submitted
- 3 Oct 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant data would be protected under the Ethical Board of Hospital University Sains Malaysia .
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05576610
- Acronym / sponsor ID
- HUSMalaysia
- Conditions
- Gingivitis, Plaque Induced Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzyme containing mouth spray + Standard Preventive Advice | Experimental | Procedure: Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)Usage of Oral7 mouth spray along side with the Standard Preventive Advice |
| Normal Saline mouth spray +Standard Preventive Advice | Placebo comparator | Procedure: Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )Usage of normal saline containing mouth spray along side with the Standard Preventive Advice |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of age group 4-7
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray)Also: Oral7 mouth sprayThe 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. | Procedure or surgery | Enzyme containing mouth spray + Standard Preventive Advice |
| Standard Preventive Advice + placebo mouth spray ( normal saline mouth spray )Also: Normal Saline Mouth SprayThe 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. | Procedure or surgery | Normal Saline mouth spray +Standard Preventive Advice |
Primary outcome
Plaque Score
Time frame: 4 weeks
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
1 secondary outcome
Gingivitis Score
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No. Individual Participant data would be protected under the Ethical Board of Hospital University Sains Malaysia .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ashwini M.Madawana, BDS principal investigator
Hospital Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard preventive advice+ enzymatic mouth sprays ( Oral7 mouth spray) in people with Gingivitis and Plaque Induced Gingivitis, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.