Dentinal HypersensitivityPhase 2NCT02008500
Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity
A Phase 2 study testing Herbal Mouthwash and Non Herbal Mouthwash in people with Dentinal Hypersensitivity, run by Government Dental College and Research Institute, Bangalore.
Trial summary
Aim of this study was to assess and compare the efficacy of a commercially available novel herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo and non herbal potassium nitrate over a period of 12 weeks. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- Herbal Mouthwash and Non Herbal Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Sep 2013
- Phase
- Phase 2
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with a history of DH caused by gingival recession or cervical erosion were selected at baseline. Subjects with a minimum 20 natural permanent teeth and at least two teeth with a VAS score of ≥4 were included in the study.
Who cannot join
- of teeth with caries, defective restorations, chipped teeth and deep periodontal pockets (probing depth >4 mm). Also, the subjects who had undergone periodontal surgery within the previous six months, and those with orthodontic appliances or bridge work that would interfere with evaluation were excluded. Subjects with the presence of occlusal overload or occlusal adjustment recently made in the tooth to be studied were also excluded. Subjects who had undertaken treatment with any product that could influence the DH of the patient in the 30 days prior to baseline were excluded. Also, the subjects with allergy to the ingredients used in the study or exhibiting any gross oral pathology, eating disorders, chronic disease, pregnancy and lactation, acute myocardial infarction within the past six months, uncontrolled metabolic disease, major psychiatric disorder, heavy smoking or alcohol abuse, any systemic disease or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines were excluded from the study.
About this study
Official title: COMPARISON OF CLINICAL EFFICACY OF A HERBAL AND A NON HERBAL MOUTHWASH ON DENTINAL HYPERSENSITIVITY: A TRIPLE MASKED RANDOMIZED CONTROLLED CLINICAL TRIAL
Aim of this study was to assess and compare the efficacy of a commercially available novel herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo and non herbal potassium nitrate over a period of 12 weeks.
Read the detailed description
A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the placebo mouthwash, Group 2 was given the herbal mouthwash ( Hiora K, which contains potassium nitrate derived from Suryakshara plant) and Group 3 was given the non herbal mouthwash (Containing non herbal potassium nitrate). Sensitivity scores (VAS score) were recorded at baseline, 3 weeks, 6 weeks and 12 weeks.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- placebo mouthwash, Herbal Mouthwash, Non Herbal Mouthwash
- Keywords
- Dentinal Hypersensitivity, Gingival Recession, Visual Analogue Score
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo mouthwashOther
15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Herbal MouthwashOther
15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Non Herbal MouthwashOther
15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Mouthwash Group | Placebo comparator | Group 1 (placebo mouthwash group) contained 51 individuals Receives: Other: placebo mouthwash |
| Herbal Mouthwash Group | Active comparator | Group 2 ( Herbal mouthwash) contained 52 individual Receives: Other: Herbal Mouthwash |
| Non Herbal Mouthwash Group | Sham comparator | Group 3 (Non Herbal mouthwash) contained 50 individuals Receives: Other: Non Herbal Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale score for Dentinal Hypersensitivity
Based on a 10-cm VAS score which was used to measure tooth sensitivity, a pain-free response was allotted a score of zero whereas a score of 10 was given to subjects with excruciating pain or discomfort.
Measured: Change in VAS score from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal HypersensitivityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Collaborators
- Himalaya Drug Company Research and Development, Makali, Bangalore, India
- Responsible party
- Principal investigator, Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
- Investigators
- Avani R Pradeep, MDS, Principal investigator, GDCRI, Bangalore, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008500
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF CLINICAL EFFICACY OF A HERBAL AND A NON HERBAL MOUTHWASH ON DENTINAL HYPERSENSITIVITY: A TRIPLE MASKED RANDOMIZED CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT02008500
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014
- Conditions
- Dentinal Hypersensitivity
- Keywords
- Dentinal Hypersensitivity, Gingival Recession, Visual Analogue Score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Collaborators
- Himalaya Drug Company Research and Development, Makali, Bangalore, India
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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.
Aim of this study was to assess and compare the efficacy of a commercially available novel herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo and non herbal potassium nitrate over a period of 12 weeks.
Detailed description
A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the placebo mouthwash, Group 2 was given the herbal mouthwash ( Hiora K, which contains potassium nitrate derived from Suryakshara plant) and Group 3 was given the non herbal mouthwash (Containing non herbal potassium nitrate). Sensitivity scores (VAS score) were recorded at baseline, 3 weeks, 6 weeks and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Mouthwash Group | Placebo comparator | Other: placebo mouthwashGroup 1 (placebo mouthwash group) contained 51 individuals |
| Herbal Mouthwash Group | Active comparator | Other: Herbal MouthwashGroup 2 ( Herbal mouthwash) contained 52 individual |
| Non Herbal Mouthwash Group | Sham comparator | Other: Non Herbal MouthwashGroup 3 (Non Herbal mouthwash) contained 50 individuals |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with a history of DH caused by gingival recession or cervical erosion were selected at baseline. Subjects with a minimum 20 natural permanent teeth and at least two teeth with a VAS score of ≥4 were included in the study.
Key exclusion criteria (1 listed)
- of teeth with caries, defective restorations, chipped teeth and deep periodontal pockets (probing depth >4 mm). Also, the subjects who had undergone periodontal surgery within the previous six months, and those with orthodontic appliances or bridge work that would interfere with evaluation were excluded. Subjects with the presence of occlusal overload or occlusal adjustment recently made in the tooth to be studied were also excluded. Subjects who had undertaken treatment with any product that could influence the DH of the patient in the 30 days prior to baseline were excluded. Also, the subjects with allergy to the ingredients used in the study or exhibiting any gross oral pathology, eating disorders, chronic disease, pregnancy and lactation, acute myocardial infarction within the past six months, uncontrolled metabolic disease, major psychiatric disorder, heavy smoking or alcohol abuse, any systemic disease or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines were excluded from the study.
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 |
|---|---|---|
| placebo mouthwash15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks | Other | Placebo Mouthwash Group |
| Herbal Mouthwash15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks | Other | Herbal Mouthwash Group |
| Non Herbal Mouthwash15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks | Other | Non Herbal Mouthwash Group |
Primary outcome
Visual Analogue Scale score for Dentinal Hypersensitivity
Time frame: Change in VAS score from Baseline to 12 weeks
Based on a 10-cm VAS score which was used to measure tooth sensitivity, a pain-free response was allotted a score of zero whereas a score of 10 was given to subjects with excruciating pain or discomfort.
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 11 Dec 2013.
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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.
Avani R Pradeep, MDS principal investigator
GDCRI, Bangalore, INDIA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbal Mouthwash and Non Herbal Mouthwash in people with Dentinal Hypersensitivity, run by Government Dental College and Research Institute, Bangalore.
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 1 inclusion and 1 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual Analogue Scale score for Dentinal Hypersensitivity (time frame: Change in VAS score from Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2013.