Dentinal HypersensitivityPhase 2NCT03741309
Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate on Dentinal Hypersensitivity
A Phase 2 study testing 5% fluorocalcium phosphosilicate dentifrice and Calcium sodium phosphosilicate in people with Dentinal Hypersensitivity, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
Trial summary
Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- 5% fluorocalcium phosphosilicate dentifrice and Calcium sodium phosphosilicate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteIndia
- Study dates
- 20 Dec 2017to 24 Feb 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.
Who cannot join
- Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontics, GDCRI Bangalore
Bangalore, Karnataka, 560002
About this study
Official title: Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate and to a Placebo on Dentinal Hypersensitivity : a Randomized Clinical Trial
Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.
Read the detailed description
A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- 5% fluorocalcium phosphosilicate dentifrice, Calcium sodium phosphosilicate, Placebo dentrifice
- Keywords
- dentinal hypersensitivity, visual analog scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% fluorocalcium phosphosilicate dentifriceOther
dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks.
Calcium sodium phosphosilicateOther
Calcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks.
Placebo dentrificeOther
placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks. Receives: Other: 5% fluorocalcium phosphosilicate dentifrice |
| Group II | Sham comparator | dentifrice containing Calcium sodium phosphosilicate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks . Receives: Other: Calcium sodium phosphosilicate |
| Group III | Placebo comparator | dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks. Receives: Other: Placebo dentrifice |
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 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start20 Dec 2017
- Primary completion16 Feb 2018
- Study completion24 Feb 2018
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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Collaborators
- Group Pharma
- 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
- NCT03741309
- Sponsor's protocol ID
- GDCRI/ACM/PG/Ph.D/5/2016-2017N
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate and to a Placebo on Dentinal Hypersensitivity : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03741309
- Acronym / sponsor ID
- GDCRI/ACM/PG/Ph.D/5/2016-2017N
- Conditions
- Dentinal Hypersensitivity
- Keywords
- dentinal hypersensitivity, visual analog scale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Collaborators
- Group Pharma
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 24 Feb 2018 (actual)
- First posted
- 14 Nov 2018 (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.
Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.
Detailed description
A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 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 |
|---|---|---|
| Group I | Active comparator | Other: 5% fluorocalcium phosphosilicate dentifricedentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks. |
| Group II | Sham comparator | Other: Calcium sodium phosphosilicatedentifrice containing Calcium sodium phosphosilicate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks . |
| Group III | Placebo comparator | Other: Placebo dentrificedentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.
Key exclusion criteria (1 listed)
- Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.
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 |
|---|---|---|
| 5% fluorocalcium phosphosilicate dentifricedentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks. | Other | Group I |
| Calcium sodium phosphosilicateCalcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks. | Other | Group II |
| Placebo dentrificeplacebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks. | Other | Group III |
Primary outcome
Visual Analogue Scale score for Dentinal Hypersensitivity
Time frame: Change in VAS score from Baseline to 6 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 14 Nov 2018.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% fluorocalcium phosphosilicate dentifrice and Calcium sodium phosphosilicate in people with Dentinal Hypersensitivity, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
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 14 Nov 2018. 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 India. 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. 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 6 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 14 Nov 2018.