Comparing the Antiplaque Effects of Novel Titania Nanoparticle Infused Fluoride Varnish vs Conventional Fluoride Varnish in Fixed Orthodontic Patients.
Comparing the Antiplaque Efficacy of Titania Nanoparticle Infused Fluoride Varnish vs Conventional Fluoride Varnish in Fixed Orthodontic Patients-A Triple Blind Randomised Controlled Trial.
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 18, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 25, 2025
September 1, 2025
1.7 years
September 12, 2025
September 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
6 months
Study Arms (2)
Group A
EXPERIMENTALGroup A will receive topical application of conventional fluoride varnish.
Group B
EXPERIMENTALGroup B will receive topical application of titania nanoparticle infused varnish.
Interventions
Group A will receive conventional fluoride varnish for antiplaque effects.Plaque will be assessed quantitatively by modified plaque index.
Group B will receive topical application of titania nanoparticle infused fluoride varnish for antiplaque effects.Plaque will be assessed quantitatively by modified plaque index.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient undergoing any antibiotic therapy.
- Patients with any craniofacial abnormality.
- Patient with mixed dentition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pakistan Institute of Medical Sciences
Islamabad, Pakistan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 18, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
September 25, 2025
Record last verified: 2025-09