Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel

August 27, 2026 updated by: Afsheen Mansoor, Pakistan Institute of Medical Sciences

Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel on Tooth Whitening and Hypersensitivity: A Randamized Clinical Trial.

The goal of this clinical trial is to learn the effect of Nano-fortified Bleaching on whitening and sensitivity of teeth.The main questions it aims to answer are:

Does Nano-fortified Bleaching gel is more effective in enhancing the whitening in comparison to conventional bleaching gel ? Does Nano-fortified Bleaching gel is more effective in declining the sensitivity in comparison to conventional bleaching gel ?

Participants will be divided into 2 groups i.e Group A where Nano-fortified Bleaching agent will be employed and Group B where Conventional Bleaching agent without nanoparticles will be used. Two application of bleaching for 16 minutes twice with total of thirty two minutes in a single session will be carried out . Tooth sensitivity will be measured by VAS Scale having "No Pain" at one-end and "Worst Pain" at opposite-end .Color change will be measured with spectrophotometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This triple blinded randomized clinical trial will be performed where Participants without any caries, restorations or periodontal disease in anterior teeth having shade A3 or darker will be included in this trial. Those having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth will be excluded. Consecutive non probability sampling technique will be used where total participants (n=60) will be randomly allocated into two groups 'A' and 'B' (n= 30). After informed consent, bleaching protocol will be carried out in both the groups 'A' and 'B'with conventional and novel bleaching gel. The color change (ΔE) and post bleaching hypersensitivity scores will be recorded by Visual analogue scale (VAS). In group A; Nano-fortified Novel TiHP gel (Titanium Dioxide nanoparticles and 25 % Hydrogen Peroxide ) will be used for the participants of Group-A and Conventional bleaching gel (25 % Hydrogen Peroxide) will be utilized for participants of Group-B. The color change (ΔE) will be investigated via spectrophotometer and VAS score will be calculated by participants who will be instructed to rate their hypersensitivity scores after 1st session, 2nd session, 3rd session and post-bleaching after 1 week and 1 month

Study Type

Interventional

Enrollment (Actual)

60

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

  • Pakistan
    • Punjab Province
      • Islamabad, Punjab Province, 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:Patients enrolled in the current trial ranged between 20- 40 years old with good general and oral health. Participants selected without any caries, restorations or periodontal disease in anterior teeth. The selected participants possessed maxillary incisors having shade A3 or darker after checking with Vita Classical Shade Guide

Exclusion Criteria:The patients having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth shall be excluded from this study. Moreover, pregnant, lactating women, smokers, patients taking medications, those having fixed orthodontic appliances and undergone tooth whitening will be also excluded

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
Experimental: Group A (Nano-reinforced Hydrtogen peroxide ) Nano-reinforced hydrogen peroxide bleaching gel
Drug: Nano-reinforced Novel Hydrogen peroxide gel
Group A (Novel Nano-enriched Hydrogen peroxide bleaching gel with Silky Corn hair fiber derived- titania nanoparticles)
Experimental: Group-B
Group-B (Conventional Hydrogen peroxide) Conventional Hydrogen peroxide gel without nanoparticles
Drug: Conventional Hydrogen peroxide gel without nanoparicles
Drug: Hydrogen peroxide without nanoparicles Group B ( Conventional Hydrogen peroxide gel without nanoparticles)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-bleaching sensitivity
Time Frame: 3 months
Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-bleaching whitening
Time Frame: 3 months
Color change shall be measured with spectrophotometer; and calculated through formula; ΔE = [(ΔL*)2 + (Δa*)2 + (Δb*)2 ] 1/2 with different readings taken by two calibrated evaluators.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

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.

General Publications

Helpful Links

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 27, 2024

Study Completion (Actual)

December 27, 2024

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD/ ERB/2023/31-01

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

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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