High Caries Risk PatientsPhase 4NCT04254835
Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish
A Phase 4 study testing Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein and Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein in people with High Caries Risk Patients, run by Cairo University at 1 site in Egypt.
Trial summary
Two different Fluoride varnish systems(Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride (CPC) and conventional fluoride) will be applied to high caries risk patients to assess their clinical effects on plaque accumulation and plaque bacterial count . Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- High Caries Risk Patients
- What is being tested?
- Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein and Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 Aug 2020
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with good general state of health.
- No signs of periodontitis.
- Patients had a recorded high bacterial count after caries risk assessment.
- No antibiotic treatment within 1 month prior to the start of the trial.
- No current medication with anti-inflammatory drugs.
- No use of antiseptic mouth rinses.
- Non-smokers.
Who cannot join
- Patients with disabilities, systemic disease or severe medical conditions.
- Patients with severe or active periodontal disease.
- Antibiotic treatment within 1 month prior to the start of the trial.
- Current medication with anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry Cairo Universty
Giza, 00202
Amir I Hafez, Associate Professor, +201100001278 ext. 00202, amir.hafez@dentistry.cu.edu.eg
About this study
Official title: Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish Among High Caries Risk Patients: Randomized Clinical Trial
Two different Fluoride varnish systems(Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride (CPC) and conventional fluoride) will be applied to high caries risk patients to assess their clinical effects on plaque accumulation and plaque bacterial count .
Read the detailed description
Preoperative steps:
- The diagnostic chart will be filled including all data about the patient's medical history, dental history, plaque assessment and plaque bacterial count.
- Scaling and polishing will be carried out for subjects. clinical steps:
- Control Group: Conventional Fluoride varnish (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
- Intervention Group: Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
Each participant will be assessed for plaque retention using plaque index and Standardized photography and image analysis to disclosed dental plaque, and plaque bacterial count using culture media sensitive for mutans streptococci (MS) in the following intervals:
- Enrolment Baseline assessment
- First visit (2nd week)
- Second visit (4th week)
- Third visit (12th week)
- Fourth visit (24th week)
- Conditions
- High Caries Risk Patients
- Being tested
- Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein, Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervitec F, Ivoclar Vivadent - Schaan LiechtensteinDrug
Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride
Fluor Protector, Ivoclar Vivadent - Schaan LiechtensteinDrug
Conventional Fluoride varnish
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will applied to this group once at the beginning of the study.Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks. Receives: Drug: Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein |
| control group | Active comparator | Varnish containing Fluoride (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein). will applied to this group once at the beginning of the study.
Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks. Receives: Drug: Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Retention
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Measured: Patient will be evaluated at 2nd week of the study in the morning before teeth brushing.
Plaque Retention
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Measured: Patient will be evaluated at 4th week of the study in the morning before teeth brushing.
Plaque Retention
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Measured: Patient will be evaluated at 12th week of the study in the morning before teeth brushing.
Plaque Retention
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Measured: Patient will be evaluated at 24th week of the study in the morning before teeth brushing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Caries Risk PatientsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Hesham Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254835
- Sponsor's protocol ID
- 221091
- Status last verified
- Feb 2020
- First submitted
- 15 Jul 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish Among High Caries Risk Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04254835
- Acronym / sponsor ID
- 221091
- Conditions
- High Caries Risk Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
Two different Fluoride varnish systems(Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride (CPC) and conventional fluoride) will be applied to high caries risk patients to assess their clinical effects on plaque accumulation and plaque bacterial count .
Detailed description
Preoperative steps:
- The diagnostic chart will be filled including all data about the patient's medical history, dental history, plaque assessment and plaque bacterial count.
- Scaling and polishing will be carried out for subjects. clinical steps:
- Control Group: Conventional Fluoride varnish (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
- Intervention Group: Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
Each participant will be assessed for plaque retention using plaque index and Standardized photography and image analysis to disclosed dental plaque, and plaque bacterial count using culture media sensitive for mutans streptococci (MS) in the following intervals:
- Enrolment Baseline assessment
- First visit (2nd week)
- Second visit (4th week)
- Third visit (12th week)
- Fourth visit (24th week)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Cervitec F, Ivoclar Vivadent - Schaan LiechtensteinVarnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will applied to this group once at the beginning of the study.Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks. |
| control group | Active comparator | Drug: Fluor Protector, Ivoclar Vivadent - Schaan LiechtensteinVarnish containing Fluoride (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein). will applied to this group once at the beginning of the study. Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with good general state of health.
- No signs of periodontitis.
- Patients had a recorded high bacterial count after caries risk assessment.
- No antibiotic treatment within 1 month prior to the start of the trial.
- No current medication with anti-inflammatory drugs.
Key exclusion criteria (4 listed)
- Patients with disabilities, systemic disease or severe medical conditions.
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 |
|---|---|---|
| Cervitec F, Ivoclar Vivadent - Schaan LiechtensteinFluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride | Drug | intervention group |
| Fluor Protector, Ivoclar Vivadent - Schaan LiechtensteinConventional Fluoride varnish | Drug | control group |
Primary outcome
Plaque Retention
Time frame: Patient will be evaluated at 2nd week of the study in the morning before teeth brushing.
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Plaque Retention
Time frame: Patient will be evaluated at 4th week of the study in the morning before teeth brushing.
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Plaque Retention
Time frame: Patient will be evaluated at 12th week of the study in the morning before teeth brushing.
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Plaque Retention
Time frame: Patient will be evaluated at 24th week of the study in the morning before teeth brushing.
Checked using a disclosing agent by Silness and Löe Dental Plaque index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein and Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein in people with High Caries Risk Patients, 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 7 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hadeer H Mohamed (01015779373 ext. 00202, hadeer.hesham91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Retention (time frame: Patient will be evaluated at 2nd week of the study in the morning before teeth brushing.). The study lists 4 primary outcomes in all. 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 5 Feb 2020.