Clinical trial NCT06904118: Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel
Official title: Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel on Tooth Whitening and Hypersensitivity: A Randamized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Tooth Sensitivity
Keywords: Biowaste,
Hypersensitivity
Silky Corn Hair Fiber
Titanium oxide nanoparticles (TiO2 Nps)
whitening
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2025-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional Study Model: Parallel Assignment
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Post-bleaching sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: Post-bleaching whitening
timeFrame: 3 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Pakistan Institute of Medical Sciences
state: Punjab
Study officials:
affiliation: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
name: Afsheen Mansoor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.