NCT06904118

Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pakistan Institute of Medical Sciences · Other Government
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

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 35 % Hydrogen Peroxide ) will be used for the participants of Group-A and Conventional bleaching gel (35 % 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

Conditions

• Tooth Discoloration
• Tooth Sensitivity

Interventions

Type	Name	Description
DRUG	Nano-reinforced Novel Hydrogen peroxide gel	Group A (Novel Nano-enriched Hydrogen peroxide bleaching gel with Silky Corn hair fiber derived- titania nanoparticles)
DRUG	Conventional Hydrogen peroxide gel without nanoparicles	Drug: Hydrogen peroxide without nanoparicles Group B ( Conventional Hydrogen peroxide gel without nanoparticles)

Timeline

• Start date: 2023-06-13
• Primary completion: 2023-12-27
• Completion: 2023-12-27
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

1 site across 1 country: Pakistan