Prevention of Dental CariesNCT04032184
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
A study testing Fluoride toothpaste, fluoride toothpaste and chlorhexidine mouthwash and fluoride toothpaste, chlorhexidine mouthwash, MI varnish in people with Prevention of Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Dental Caries
- What is being tested?
- Fluoride toothpaste, fluoride toothpaste and chlorhexidine mouthwash and fluoride toothpaste, chlorhexidine mouthwash, MI varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Nov 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 20-50 years
- High caries risk patients defined according to cariogram caries risk assessment model
- On non-cariogenic diet
- High plaque index
- Systematically healthy
- No orthodontic or prosthodontic appliance
Who cannot join
- Age range less than 20 or more than 50 years
- Low or moderate caries risk patients according to cariogram
- Patients with a compromised medical history
- Cariogenic diet patient
- Participants with a history of allergy to any of the drugs or chemicals used in the study
- Patients on any antibiotics during the past month
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Howaida Fakhry Fouad
Giza, Other, 8655
howaida f fouad, Phd, 00201010008948, howaidafakhry@gmail.com
Esraa A Ahmed, Phd, 00201020614170, ososdent@hotmail.com
About this study
66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data
- Conditions
- Prevention of Dental Caries
- Being tested
- Fluoride toothpaste, fluoride toothpaste and chlorhexidine mouthwash, fluoride toothpaste, chlorhexidine mouthwash, MI varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride toothpasteOther
regimen using fluoride toothpaste
fluoride toothpaste and chlorhexidine mouthwashOther
regimen using fluoride toothpaste and chlorhexidine mouthwash
fluoride toothpaste, chlorhexidine mouthwash, MI varnishOther
regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish
| Study group | Role | What they receive |
|---|---|---|
| Fluoride toothpaste | Active comparator | Not described Receives: Other: Fluoride toothpaste |
| fluoride toothpaste and chlorhexidine mouthwash | Experimental | Not described Receives: Other: fluoride toothpaste and chlorhexidine mouthwash |
| fluoride toothpaste, chlorhexidine mouthwash, MI varnish | Experimental | Not described Receives: Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Risk Assessment
will be evaluated by cariogram
Measured: an average 3 months
Secondary outcomes (1)
DMF scores
will be evaluated by ICDAS
Measured: an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howaida Fakhry Fouad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032184
- Sponsor's protocol ID
- 1234567
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04032184
- Acronym / sponsor ID
- 1234567
- Conditions
- Prevention of Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 25 Jul 2019 (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.
66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride toothpaste | Active comparator | Other: Fluoride toothpaste |
| fluoride toothpaste and chlorhexidine mouthwash | Experimental | Other: fluoride toothpaste and chlorhexidine mouthwash |
| fluoride toothpaste, chlorhexidine mouthwash, MI varnish | Experimental | Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range 20-50 years
- High caries risk patients defined according to cariogram caries risk assessment model
- On non-cariogenic diet
- High plaque index
- Systematically healthy
Key exclusion criteria (6 listed)
- Age range less than 20 or more than 50 years
- Low or moderate caries risk patients according to cariogram
- Patients with a compromised medical history
- Cariogenic diet patient
- Participants with a history of allergy to any of the drugs or chemicals used in the study
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 |
|---|---|---|
| Fluoride toothpasteregimen using fluoride toothpaste | Other | Fluoride toothpaste |
| fluoride toothpaste and chlorhexidine mouthwashregimen using fluoride toothpaste and chlorhexidine mouthwash | Other | fluoride toothpaste and chlorhexidine mouthwash |
| fluoride toothpaste, chlorhexidine mouthwash, MI varnishregimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish | Other | fluoride toothpaste, chlorhexidine mouthwash, MI varnish |
Primary outcome
Caries Risk Assessment
Time frame: an average 3 months
will be evaluated by cariogram
1 secondary outcome
DMF scores
Time frame: an average of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride toothpaste, fluoride toothpaste and chlorhexidine mouthwash and fluoride toothpaste, chlorhexidine mouthwash, MI varnish in people with Prevention of Dental Caries, run by Cairo University 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact howaida f fouad, Phd (00201010008948, howaidafakhry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries Risk Assessment (time frame: an average 3 months). 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 25 Jul 2019.