Clinical trial NCT06790953: Efficacy of Novel Titania Nanoparticles Enriched Mouth Wash in Treating Dentine Hypersensitivity
Official title: Clinical Efficacy of Novel Biogenically Fabricated Titania Nanoparticles Enriched Mouth Wash in Treating the Tooth Dentine Hypersensitivity: a Randamized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentine Hypersensitivity
Keywords: Bacillus coagulans
Biogenic
Dentin Hypersensitivity
Nanoparticles
Titanium oxide (TiO2 Nps)
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants will be allocated in two groups by Consecutive random sampling technique
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post mouth wash utilization Dentine Hypersensitivity
timeFrame: 3 months
Secondary outcomes:
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: Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30.