- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06790953
Efficacy of Novel Titania Nanoparticles Enriched Mouth Wash in Treating Dentine Hypersensitivity
January 31, 2025 updated by: Afsheen Mansoor, Pakistan Institute of Medical Sciences
Clinical Efficacy of Novel Biogenically Fabricated Titania Nanoparticles Enriched Mouth Wash in Treating the Tooth Dentine Hypersensitivity: a Randamized Clinical Trial
Randomized Clinical trial to compare the reduction in dentin hypersensitivity after incorporating biogenically fabricated titania nanoparticles enriched Mouth Wash and Conventional Mouth Wash.Participants ranging between 20-50 years were allocated in two groups.
Group A will use Conventional Mouth Wash without Nanoparticles.
Group B will use titania nanoparticles enriched Mouth Wash.
Both will use them for three months and then their VAS scoring will be checked.
Study Overview
Status
Completed
Conditions
Detailed Description
In this study Novel biogenically fabricated titania nanoparticle reinforced Mouth Wash will be evaluated for dentine sensitivity .
Participants following Inclusion criteria will be allocated in this study by Consecutive random sampling technique.
Participants will be divided into two groups i.e Group-A and Group-B with dentin sensitivity of 30-80.
Group A will be given Conventional Mouth Wash for three months and Group-B will be given titania nanoparticles enriched Mouth Wash for three months for the sensitivity.
Sensitivity will be assessed using Visual analog scale (VAS) mean score after 1 month and then three months.
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 44080
- School of Dentistry, Pakistan Institute of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants ranging between 20-50 years, good general health but developed dentine sensitivity associated with tooth surface wear and loss during the past 6 months.
- There was no history of allergy.
- Participants did not use any mouth wash , dentifrice or medication in the last 3 months.
- The involved teeth were viable, non-shaky, devoid of any decay, cracks and fillings.
- There was an essential positive response to the provoking Air stimuli.
- These teeth should display the visible signs of tooth loss and wear such as : attrition, abrasion, erosion and abfraction.
Exclusion Criteria:
- Participants that might have developed allergy or used medications during the last 2 weeks or more.
- The teeth having cracks, decay and fillings were also excluded. Patients who have undergone any periodontal surgery or gross periodontal issues.
- Participants who used any desensitisizing toothpastes/mouthwashes and tooth bleaching agents within 2 months of the trial were also excluded positively.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group-A: Conventional Mouth wash .
Group A will receive conventional mouthwash for treatment of dentin hypersensitivity
|
In Group- A Conventional Sensed Mouth Wash will be used for treatment of Dentin hypersensitivity. Visual Analogue scoring system will be used to calculate the dentin hypersensitivity. |
|
Experimental: Group-B: Novel Titania nanoparticles Mouth wash
Group B will receive novel Titania nano particles reinforced mouthwash for treatment of dentin hypersensitivity
|
In Group-B Novel Titania nanoparticles enriched Mouth wash will be used to treat the Dentin hypersensitivity. Visual Analogue scoring system will be used to calculate the dentin hypersensitivity. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post mouth wash utilization Dentine Hypersensitivity
Time Frame: 3 months
|
Evaluation of dentine hypersensitivity with Conventional Mouth Wash without titania nanoparticles and Novel Nps Mouth Wash with titania nanoparticles on human tooth dentin.
Visual analog scale with scoring from 0 to 100 where Score 100 means worst outcomes.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Afsheen Mansoor, PhD, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2024
Primary Completion (Actual)
December 3, 2024
Study Completion (Actual)
December 3, 2024
Study Registration Dates
First Submitted
January 18, 2025
First Submitted That Met QC Criteria
January 18, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 31, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOD/ERB/2024/36-200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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