Dental PlaqueNCT05979636
Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children
A study testing Novamin containing toothpaste and Fluoride containing toothpaste in people with Dental Plaque and Dental Caries, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans in the plaque of high caries-risk children. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Dental Plaque, Dental Caries
- What is being tested?
- Novamin containing toothpaste and Fluoride containing toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2022to 1 Jan 2023
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medically healthy children.
- No erupting first permanent molars.
- High caries risk children; Have visible cavities or have a visible plaque on their teeth.
- Cooperative (Positive or definitely positive), according to Frankl's Behavior Rating Scale
Who cannot join
- History of intake of antibiotics for the past 3-4 weeks.
- History of professional fluoride treatment over 2 weeks before the study.
- Children with tooth structure defects.
- Children unable to return for recall visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)
Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans in the plaque of high caries-risk children.
- Conditions
- Dental Plaque, Dental Caries
- Being tested
- Novamin containing toothpaste, Fluoride containing toothpaste
- Medical subject headings
- Dental Plaque, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novamin containing toothpasteOther
children's teeth will be brushed using Novamin containing toothpaste.
Fluoride containing toothpasteOther
children's teeth will be brushed using Fluoride containing toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Novamin containing toothpaste |
| Control group | Active comparator | Not described Receives: Other: Fluoride containing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bacterial count in dental plaque
The samples will be collected from all children in the study and the level of S.mutans will be recorded.
Measured: 1 week, 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start6 Dec 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979636
- Sponsor's protocol ID
- 0286-09/2021
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05979636
- Acronym / sponsor ID
- 0286-09/2021
- Conditions
- Dental Plaque, Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Aug 2023 (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.
Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans in the plaque of high caries-risk children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Novamin containing toothpaste |
| Control group | Active comparator | Other: Fluoride containing toothpaste |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Medically healthy children.
- No erupting first permanent molars.
- High caries risk children; Have visible cavities or have a visible plaque on their teeth.
- Cooperative (Positive or definitely positive), according to Frankl's Behavior Rating Scale
Key exclusion criteria (4 listed)
- History of intake of antibiotics for the past 3-4 weeks.
- History of professional fluoride treatment over 2 weeks before the study.
- Children with tooth structure defects.
- Children unable to return for recall visits
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 |
|---|---|---|
| Novamin containing toothpastechildren's teeth will be brushed using Novamin containing toothpaste. | Other | Test group |
| Fluoride containing toothpastechildren's teeth will be brushed using Fluoride containing toothpaste. | Other | Control group |
Primary outcome
Change in bacterial count in dental plaque
Time frame: 1 week, 2 weeks and 4 weeks
The samples will be collected from all children in the study and the level of S.mutans will be recorded.
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 7 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novamin containing toothpaste and Fluoride containing toothpaste in people with Dental Plaque and Dental Caries, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 4 inclusion and 4 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 7 Aug 2023. 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 Egypt. 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. 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?
Change in bacterial count in dental plaque (time frame: 1 week, 2 weeks and 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 7 Aug 2023.