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

NCT ID: NCT06288776

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tooth Sensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In this study, participants will be selected by consecutive non-random sampling technique.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Single-blinded study where participant will be masked.

Study Groups

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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

Group Type EXPERIMENTAL

Herbal based mouthwash

Intervention Type DIAGNOSTIC_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

Interventions

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Herbal 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Afsheen Mansoor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Afsheen Mansoor, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

Locations

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Afsheen Mansoor

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30803493 (View on PubMed)

Other Identifiers

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SOD/ERB/2023/22-04

Identifier Type: -

Identifier Source: org_study_id

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