NCT06288776

Brief Summary

Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients. Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 24, 2024

Last Update Submit

February 24, 2024

Conditions

Keywords

Azadirachta indicaGingival IndexHerbalMouthwashTooth sensitivity

Outcome Measures

Primary Outcomes (1)

  • Toothsensitivity declination with herbal based mouthwash

    Evaluation of herbal based mouth wash in eliminating the tooth sensitivity ranging between VAS scores 30-80.

    3 months

Study Arms (1)

Interventional Group

EXPERIMENTAL

Participants will be assessed for their tooth sensitivity (VAS scoring) and after giving herbal based mouthwash sensitivity will be assessed after 3 months

Diagnostic Test: Herbal based mouthwash

Interventions

Herbal based mouthwashDIAGNOSTIC_TEST

Herbal based mouthwash will be used to treat the tooth sensitivity in participants having VAS score values of tooth sensitivity ranging between 30-80

Interventional Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with good general health and no allergy
  • Patients who have not used any mouthwash in last 3 month
  • Study teeth shall be free of decay and restoration
  • Study teeth shalll not be mobile
  • Study teeth shall have the Gingival Index score 3
  • Participants shall be able to read ,write and willing to give consent.

You may not qualify if:

  • Patients with poor general health and allergies
  • Patients who have used any mouthwash in last 3 months
  • Teeth with decay and restorations
  • Teeth with mobility
  • Teeth with Gingival Index score more than 3
  • Participants that wonn't be able to read ,write and willing to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afsheen Mansoor

Islamabad, 44080, Pakistan

Location

Related Publications (1)

  • Hall C, Sufi F, Milleman JL, Milleman KR. Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study. J Am Dent Assoc. 2019 Mar;150(3):204-212. doi: 10.1016/j.adaj.2018.10.023.

    PMID: 30803493BACKGROUND

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
NA
Masking
NONE
Masking Details
Single-blinded study where participant will be masked.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: In this study, participants will be selected by consecutive non-random sampling technique.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2024

First Posted

March 1, 2024

Study Start

February 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations