NCT06790953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 18, 2025

Last Update Submit

January 31, 2025

Conditions

Keywords

Bacillus coagulansBiogenicDentin HypersensitivityNanoparticlesTitanium oxide (TiO2 Nps)

Outcome Measures

Primary Outcomes (1)

  • Post mouth wash utilization Dentine Hypersensitivity

    Evaluation of dentine hypersensitivity with Conventional Mouth Wash without titania nanoparticles and Novel Nps Mouth Wash with titania nanoparticles on human tooth dentin. Visual analog scale with scoring from 0 to 100 where Score 100 means worst outcomes.

    3 months

Study Arms (2)

Group-A: Conventional Mouth wash .

EXPERIMENTAL

Group A will receive conventional mouthwash for treatment of dentin hypersensitivity

Procedure: Group- A Conventional Sensed Mouth Wash

Group-B: Novel Titania nanoparticles Mouth wash

EXPERIMENTAL

Group B will receive novel Titania nano particles reinforced mouthwash for treatment of dentin hypersensitivity

Procedure: Group-B Novel Titania nanoparticles enriched Mouth Wash

Interventions

In Group- A Conventional Sensed Mouth Wash will be used for treatment of Dentin hypersensitivity. Visual Analogue scoring system will be used to calculate the dentin hypersensitivity.

Group-A: Conventional Mouth wash .

In Group-B Novel Titania nanoparticles enriched Mouth wash will be used to treat the Dentin hypersensitivity. Visual Analogue scoring system will be used to calculate the dentin hypersensitivity.

Group-B: Novel Titania nanoparticles Mouth wash

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Pakistan Institute of Medical Sciences

Islamabad, Punjab Province, 44080, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 31592280BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic 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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
This is a triple-blinded study in which the participant, care provider and outcome assessor will be masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this study, participants will be allocated in two groups by Consecutive random sampling technique
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 24, 2025

Study Start

June 13, 2024

Primary Completion

December 3, 2024

Study Completion

December 3, 2024

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations