CariesEarly Phase 1NCT04679558
Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs
A Early Phase 1 study testing Chlorhexidine varnish added to the preventive protocol and Preventive protocol in people with Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Caries
- What is being tested?
- Chlorhexidine varnish added to the preventive protocol and Preventive protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 11 Aug 2021
- Phase
- Early Phase 1
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of disability like special needs autism and down syndrome
Who cannot join
- age below 13
Trial locations and contacts
1 site in 1 country.
About this study
This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly
Read the detailed description
This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly cause those have alot of problems concerning the accumulagio. Of plaque and so increased bacteria
- Conditions
- Caries
- Being tested
- Chlorhexidine varnish added to the preventive protocol, Preventive protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine varnish added to the preventive protocolDrug
Also called Varnish
Antibacterial agent varnish added to the preventive protocol
Preventive protocolBehavioural
Also called Caries preventive protocol
Preventive protocol
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Preventive protocol Receives: Behavioral: Preventive protocol |
| Intervention | Experimental | Adding chlorhexidine to the preventive protocol Receives: Drug: Chlorhexidine varnish added to the preventive protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Streptococcus mutans count
Antibacterial effect of chlorhexidine on streptococcus mutans count
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Sep 2020
- Primary completion15 Jul 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katreen Tawfik, Cairo University
- Investigators
- Katreen Fouad, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679558
- Sponsor's protocol ID
- 7all
- Status last verified
- Aug 2021
- First submitted
- 14 Dec 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Journal
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs
- ClinicalTrials.gov ID
- NCT04679558
- Acronym / sponsor ID
- 7all
- Conditions
- Caries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 22 Dec 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.
This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly
Detailed description
This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly cause those have alot of problems concerning the accumulagio. Of plaque and so increased bacteria
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Behavioral: Preventive protocolPreventive protocol |
| Intervention | Experimental | Drug: Chlorhexidine varnish added to the preventive protocolAdding chlorhexidine to the preventive protocol |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of disability like special needs autism and down syndrome
Key exclusion criteria (1 listed)
- age below 13
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 |
|---|---|---|
| Chlorhexidine varnish added to the preventive protocolAlso: VarnishAntibacterial agent varnish added to the preventive protocol | Drug | Intervention |
| Preventive protocolAlso: Caries preventive protocolPreventive protocol | Behavioural | Comparator |
Primary outcome
Streptococcus mutans count
Time frame: 1 year
Antibacterial effect of chlorhexidine on streptococcus mutans count
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 13 Aug 2021.
- Individual participant dataSharing planned: Yes. Journal
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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.
Katreen Fouad principal investigator
Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chlorhexidine varnish added to the preventive protocol and Preventive protocol in people with 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 1 inclusion and 1 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 13 Aug 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Streptococcus mutans count (time frame: 1 year). 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 13 Aug 2021.