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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group-A: Conventional Mouth wash .
Group A will receive conventional mouthwash for treatment of dentin hypersensitivity
Procedure: Group- A Conventional Sensed Mouth Wash

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
Procedure: Group-B Novel Titania nanoparticles enriched Mouth Wash

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pakistan Institute of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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