Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel

NCT06904118 | Completed

• 1 other identifier: SOD/ ERB/2023/31-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. One application of bleaching for thirty minutes 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.

Conditions

Tooth Discoloration; Tooth Sensitivity

Keywords

Biowaste,; Hypersensitivity; Silky Corn Hair Fiber; Titanium oxide nanoparticles (TiO2 Nps); whitening

Outcome Measures

Primary Outcomes (1)

• Post-bleaching sensitivity

  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 Outcomes (1)

• Post-bleaching whitening

  3 months

Study Arms (2)

Group-A

EXPERIMENTAL

Experimental: Group A (Nano-reinforced Hydrtogen peroxide ) Nano-reinforced hydrogen peroxide bleaching gel

Drug: Nano-reinforced Novel Hydrogen peroxide gel

Group-B

EXPERIMENTAL

Group-B (Conventional Hydrogen peroxide) Conventional Hydrogen peroxide gel without nanoparticles

Drug: Conventional Hydrogen peroxide gel without nanoparicles

Interventions

Nano-reinforced Novel Hydrogen peroxide gel DRUG

Group A (Novel Nano-enriched Hydrogen peroxide bleaching gel with Silky Corn hair fiber derived- titania nanoparticles)

Group-A

Conventional Hydrogen peroxide gel without nanoparicles DRUG

Drug: Hydrogen peroxide without nanoparicles Group B ( Conventional Hydrogen peroxide gel without nanoparticles)

Group-B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

School of Dentistry, Pakistan Institute of Medical Sciences

Islamabad, Punjab Province, 44080, Pakistan

Location

Related Publications (1)

• Coppla FM, Rezende M, de Paula E, Farago PV, Loguercio AD, Kossatz S, Reis A. Combination of Acetaminophen/Codeine Analgesics Does Not Avoid Bleaching-Induced Tooth Sensitivity: A Randomized, Triple-Blind Two-Center Clinical Trial. Oper Dent. 2018 Mar/Apr;43(2):E53-E63. doi: 10.2341/17-092-C.

  PMID: 29504880 RESULT

Related Links

• Coppla, F. M., Rezende, M., de Paula, E., Farago, P. V., Loguercio, A. D., Kossatz, S., \& Reis, A. (2018). Combination of Acetaminophen/Codeine Analgesics Does Not Avoid Bleaching-Induced Tooth Sensitivity: A Randomized, Triple-Blind Two-Center Clinical

MeSH Terms

Conditions

Tooth Discoloration; Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Afsheen Mansoor, PhD

  School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Care Provider, Outcomes Assessor) In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Interventional Study Model: Parallel Assignment

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: June 13, 2023
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)