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CompletedNCT06288776Updated Mar 1, 2024

Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity

An interventional study of Herbal based mouthwash in Tooth Sensitivity, sponsored by Pakistan Institute of Medical Sciences. Completed at 1 site in Pakistan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by Pakistan Institute of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2023, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

Read the detailed description

In this study Herbal based mouthwash will be evaluated for eliminating the tooth sensitivity in the participants having Gingival Index score 3 with VAS scores for sensitivity ranging between 30-80 . Consecutive non-random sampling technique will be used in this study where Participants included will be assessed for tooth sensitivity through Visual Analogue Scale (VAS) initially for base line readings. These participants will be given Azadirachta indica based Herbal mouthwash for three months and then again their tooth sensitivity will be assessed by Visual Analogue Scale (VAS) for final readings. The mean values of VAS scoring both before and after the usage of herbal mouth wash will be compared to investigate the clinical efficacy of this mouthwash in treating the tooth sensitivity.

02

Conditions studied

  • Tooth Sensitivity

Keywords

  • Azadirachta indica
  • Gingival Index
  • Herbal
  • Mouthwash
  • Tooth sensitivity
03

In context

Dentin Sensitivity

283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 120 is above the median of 60 across 273 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Pakistan Institute of Medical Sciences is the lead sponsor of 51 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Interventional Group

    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

  • Diagnostic testHerbal based mouthwash

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

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • Afsheen Mansoor
    Islamabad, 44080, Pakistan
08

References and documents

Publications

  • 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. PubMed 30803493 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06288776
Lead sponsor
Pakistan Institute of Medical Sciences
Responsible party
Afsheen Mansoor (Principal Investigator, Pakistan Institute of Medical Sciences) — Principal investigator
First posted
Mar 1, 2024
Start date
Feb 1, 2023
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Mar 1, 2024

Study contacts

Afsheen Mansoor, PhD
principal investigator · School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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