Dental Plaque AccumulationNCT07180849
Comparing the Antiplaque Effects of Novel Titania Nanoparticle Infused Fluoride Varnish vs Conventional Fluoride Varnish in Fixed Orthodontic Patients.
A study testing Fluoride varnish and Novel titania nanoparticle infused fluoride varnish in people with Dental Plaque Accumulation and Nanoparticles, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
In this study the investigators aimed to explore the antibiofilm effect of fluoride varnish loaded with titania nanoparticles synthesized from moringa oleifera leaves extract vs conventional fluoride varnish in multibracket fixed orthodontic patients. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque Accumulation, Nanoparticles, Fluoride Varnishes
- What is being tested?
- Fluoride varnish and Novel titania nanoparticle infused fluoride varnish
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients planned for fixed orthodontic treatment.
- Patients within age group 16-30 years.
- Patient with no history of previous orthodontic treatment.
- Patients with no active periodontal diseases.
Who cannot join
- Patient undergoing any antibiotic therapy.
- Patients with any craniofacial abnormality.
- Patient with mixed dentition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Medical Sciences
Islamabad
Afifa Fahim, +92 3322655730, afahim.afk@gmail.com
About this study
Official title: Comparing the Antiplaque Efficacy of Titania Nanoparticle Infused Fluoride Varnish vs Conventional Fluoride Varnish in Fixed Orthodontic Patients-A Triple Blind Randomised Controlled Trial.
In this study the investigators aimed to explore the antibiofilm effect of fluoride varnish loaded with titania nanoparticles synthesized from moringa oleifera leaves extract vs conventional fluoride varnish in multibracket fixed orthodontic patients.
- Being tested
- Fluoride varnish, Novel titania nanoparticle infused fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishProcedure or surgery
Group A will receive conventional fluoride varnish for antiplaque effects.Plaque will be assessed quantitatively by modified plaque index.
Novel titania nanoparticle infused fluoride varnishProcedure or surgery
Group B will receive topical application of titania nanoparticle infused fluoride varnish for antiplaque effects.Plaque will be assessed quantitatively by modified plaque index.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will receive topical application of conventional fluoride varnish. Receives: Procedure: Fluoride varnish |
| Group B | Experimental | Group B will receive topical application of titania nanoparticle infused varnish. Receives: Procedure: Novel titania nanoparticle infused fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the plaque inhibitory effect of titania nanoparticle infused fluoride varnish and conventional fluoride varnish in fixed orthodontic patients.
Plaque will be assessed quantitatively by modified plaque index.
Measured: 6 months
Secondary outcomes (1)
To measure plaque bacterial load and pH following application of titania nanoparticle infused and conventional fluoride varnish in fixed orthodontic patients.
Bacterial colonies will be morphologically identified and counted as Colony Forming Units (CFU) using a colony counting grid.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Plaque AccumulationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afifa Fahim, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180849
- Sponsor's protocol ID
- SOD/ERB/2025/91
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Antiplaque Efficacy of Titania Nanoparticle Infused Fluoride Varnish vs Conventional Fluoride Varnish in Fixed Orthodontic Patients-A Triple Blind Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07180849
- Acronym / sponsor ID
- SOD/ERB/2025/91
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 2025 (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.
In this study the investigators aimed to explore the antibiofilm effect of fluoride varnish loaded with titania nanoparticles synthesized from moringa oleifera leaves extract vs conventional fluoride varnish in multibracket fixed orthodontic patients.
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 |
|---|---|---|
| Group A | Experimental | Procedure: Fluoride varnishGroup A will receive topical application of conventional fluoride varnish. |
| Group B | Experimental | Procedure: Novel titania nanoparticle infused fluoride varnishGroup B will receive topical application of titania nanoparticle infused varnish. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients planned for fixed orthodontic treatment.
- Patients within age group 16-30 years.
- Patient with no history of previous orthodontic treatment.
- Patients with no active periodontal diseases.
Key exclusion criteria (3 listed)
- Patient undergoing any antibiotic therapy.
- Patients with any craniofacial abnormality.
- Patient with mixed dentition
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 varnishGroup A will receive conventional fluoride varnish for antiplaque effects.Plaque will be assessed quantitatively by modified plaque index. | Procedure or surgery | Group A |
| Novel titania nanoparticle infused fluoride varnishGroup B will receive topical application of titania nanoparticle infused fluoride varnish for antiplaque effects.Plaque will be assessed quantitatively by modified plaque index. | Procedure or surgery | Group B |
Primary outcome
To compare the plaque inhibitory effect of titania nanoparticle infused fluoride varnish and conventional fluoride varnish in fixed orthodontic patients.
Time frame: 6 months
Plaque will be assessed quantitatively by modified plaque index.
1 secondary outcome
To measure plaque bacterial load and pH following application of titania nanoparticle infused and conventional fluoride varnish in fixed orthodontic patients.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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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.
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 varnish and Novel titania nanoparticle infused fluoride varnish in people with Dental Plaque Accumulation and Nanoparticles, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 3 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the plaque inhibitory effect of titania nanoparticle infused fluoride varnish and conventional fluoride varnish in fixed orthodontic patients. (time frame: 6 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 Sep 2025.