Tooth SensitivityNCT06288776
Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity
A study testing Herbal based mouthwash in people with Tooth Sensitivity, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Sensitivity
- What is being tested?
- Herbal based mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Hypersensitivity of Teeth
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.
- Conditions
- Tooth Sensitivity
- Being tested
- Herbal based mouthwash
- Keywords
- Azadirachta indica, Gingival Index, Herbal, Mouthwash, Tooth sensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Herbal based mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toothsensitivity declination with herbal based mouthwash
Evaluation of herbal based mouth wash in eliminating the tooth sensitivity ranging between VAS scores 30-80.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Feb 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this study, participants will be selected by consecutive non-random sampling technique.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afsheen Mansoor, Pakistan Institute of Medical Sciences
- Investigators
- Afsheen Mansoor, PhD, Principal investigator, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288776
- Sponsor's protocol ID
- SOD/ERB/2023/22-04
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Hypersensitivity of Teeth
- ClinicalTrials.gov ID
- NCT06288776
- Acronym / sponsor ID
- SOD/ERB/2023/22-04
- Conditions
- Tooth Sensitivity
- Keywords
- Azadirachta indica, Gingival Index, Herbal, Mouthwash, Tooth sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, participants will be selected by consecutive non-random sampling technique.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Diagnostic Test: Herbal based mouthwashParticipants will be assessed for their tooth sensitivity (VAS scoring) and after giving herbal based mouthwash sensitivity will be assessed after 3 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal based mouthwashHerbal based mouthwash will be used to treat the tooth sensitivity in participants having VAS score values of tooth sensitivity ranging between 30-80 | Diagnostic test | Interventional Group |
Primary outcome
Toothsensitivity declination with herbal based mouthwash
Time frame: 3 months
Evaluation of herbal based mouth wash in eliminating the tooth sensitivity ranging between VAS scores 30-80.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 30803493Hall 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.
- Individual participant dataSharing planned: No
Related trials for Tooth Sensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
Not yet recruiting
Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars
Molar-Incisor Hypomineralization (MIH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afsheen Mansoor, PhD principal investigator
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal based mouthwash in people with Tooth Sensitivity, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toothsensitivity declination with herbal based mouthwash (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.