Clinical trial NCT06288776: Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity
Official title: Clinical Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Hypersensitivity of Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Sensitivity
Keywords: Azadirachta indica
Gingival Index
Herbal
Mouthwash
Tooth sensitivity
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2024-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this study, participants will be selected by consecutive non-random sampling technique.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Toothsensitivity declination with herbal based mouthwash
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Afsheen Mansoor
Study officials:
affiliation: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
name: Afsheen Mansoor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.