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

Tooth Sensitivity Clinical Trial

Official title:

Clinical Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Hypersensitivity of Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06288776
• Other study ID #: SOD/ERB/2023/22-04
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2024
• Source: Pakistan Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Sensitivity

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Pakistan	Afsheen Mansoor	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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