Dentine HypersensitivityPhase 3NCT03177109
Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity
A Phase 3 study testing 5% fluoride varnish, 8% arginine containing paste and Self-adhesive resin in people with Dentine Hypersensitivity, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This is a single center, randomized control. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- 5% fluoride varnish, 8% arginine containing paste and Self-adhesive resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 3 May 2017to 20 Dec 2018
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age 18 and above with dentine hypersensitivity will be selected.
- At least two hypersensitive teeth which will be sensitive to air blast (Schiff air sensitivity scores of 2 or 3) and positive tactile sensitivity assessed clinically with explorer
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Who cannot join
- • Patients who would have undergone any periodontal procedure or gotten any professionally applied desensitizers in the last three months.
- Patients having generalized sensitivity in all teeth
- Chronic use of anti-inflammatory and analgesic medications
- Pregnant or lactating females;
- Any denture bridgework; active cervical caries or deep abrasion requiring Class V fillings;
- Fractured, crowned or root filled teeth and teeth with large restorations
- Carious teeth or cracked teeth assessed on the basis of clinical judgment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 74800
Robia Ghafoor, BDS,FCPS, 02133106467, robia.ghafoor@aku.edu
Muhammad Hasan Hameed
About this study
Official title: Comparison of Fluoride Varnish With Two Different Desensitizers in Reducing Dentinal Hypersensitivity
This is a single center, randomized control. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and four weeks.
Read the detailed description
The aim of the present study is to evaluate the efficacy of three common professionally applied desensitizing agents in the reduction of dentine hypersensitivity over a period of 4 weeks. Patients presenting to the dental clinic with Dentine hypersensitivity and fulfilling the inclusion criteria will be included in the study after taking informed consent. Participants will be divided into three groups. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). the subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and at four weeks by another dentist who would be a blind assessor.
- Conditions
- Dentine Hypersensitivity
- Being tested
- 5% fluoride varnish, 8% arginine containing paste, Self-adhesive resin
- Keywords
- Dentine Hypersensitivity, Fluoride varnish, Desensitizing agents
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% fluoride varnishDrug
Also called Acclean
Applied topically as a coating at single point in time
8% arginine containing pasteDrug
Also called Colgate® Sensitive Pro-Relief™
Applied topically as a coating at single point in time
Self-adhesive resinDrug
Also called Seal and Protect, Dentsply
Applied topically as a coating at single point in time and light cured for 20 seconds
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish Group | Active comparator | 5% fluoride varnish (Acclean) applied topically Receives: Drug: 5% fluoride varnish |
| Arginine paste Group | Active comparator | 8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically Receives: Drug: 8% arginine containing paste |
| Adhesive Resin Group | Active comparator | Self-adhesive resin (Seal and Protect, Dentsply) applied topically Receives: Drug: Self-adhesive resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hypersensitivity
- Investigators are comparing the effectiveness of three professionally applied desensitizing agents, 8% arginine containing paste (Colgate® Sensitive Pro-Relief™), 5% fluoride varnish (Acclean) and self-adhesive resin (Seal and Protect, Dentsply) in reducing the dentine hypersensitivity immediately after application and at 2 and 4 weeks follow-up.The measurements of sensitivity will be determined by patient's response to air blast stimuli. Subjective responses will be recorded using Schiff Cold Air Sensitivity Scale which is scored as follows:
0 Subject does not respond to air stimulus,
- Subject responds to air stimulus but does not request discontinuation of stimulus
- Subject responds to air stimulus and requests discontinuation or moves from stimulus
- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
Measured: Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start3 May 2017
- Primary completion20 Dec 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hasan Hameed, Aga Khan University
- Investigators
- Muhammad Hasan Hameed, BDS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177109
- Sponsor's protocol ID
- 4714-Sur-ERC-17
- Status last verified
- Jun 2018
- First submitted
- 31 May 2017
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fluoride Varnish With Two Different Desensitizers in Reducing Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT03177109
- Acronym / sponsor ID
- 4714-Sur-ERC-17
- Conditions
- Dentine Hypersensitivity
- Keywords
- Dentine Hypersensitivity, Fluoride varnish, Desensitizing agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 6 Jun 2017 (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.
This is a single center, randomized control. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and four weeks.
Detailed description
The aim of the present study is to evaluate the efficacy of three common professionally applied desensitizing agents in the reduction of dentine hypersensitivity over a period of 4 weeks. Patients presenting to the dental clinic with Dentine hypersensitivity and fulfilling the inclusion criteria will be included in the study after taking informed consent. Participants will be divided into three groups. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). the subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and at four weeks by another dentist who would be a blind assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish Group | Active comparator | Drug: 5% fluoride varnish5% fluoride varnish (Acclean) applied topically |
| Arginine paste Group | Active comparator | Drug: 8% arginine containing paste8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically |
| Adhesive Resin Group | Active comparator | Drug: Self-adhesive resinSelf-adhesive resin (Seal and Protect, Dentsply) applied topically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with age 18 and above with dentine hypersensitivity will be selected.
- At least two hypersensitive teeth which will be sensitive to air blast (Schiff air sensitivity scores of 2 or 3) and positive tactile sensitivity assessed clinically with explorer
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Key exclusion criteria (7 listed)
- • Patients who would have undergone any periodontal procedure or gotten any professionally applied desensitizers in the last three months.
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% fluoride varnishAlso: AccleanApplied topically as a coating at single point in time | Drug | Fluoride Varnish Group |
| 8% arginine containing pasteAlso: Colgate® Sensitive Pro-Relief™Applied topically as a coating at single point in time | Drug | Arginine paste Group |
| Self-adhesive resinAlso: Seal and Protect, DentsplyApplied topically as a coating at single point in time and light cured for 20 seconds | Drug | Adhesive Resin Group |
Primary outcome
Reduction of hypersensitivity
Time frame: Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks
• Investigators are comparing the effectiveness of three professionally applied desensitizing agents, 8% arginine containing paste (Colgate® Sensitive Pro-Relief™), 5% fluoride varnish (Acclean) and self-adhesive resin (Seal and Protect, Dentsply) in reducing the dentine hypersensitivity immediately after application and at 2 and 4 weeks follow-up.The measurements of sensitivity will be determined by patient's response to air blast stimuli. Subjective responses will be recorded using Schiff Cold Air Sensitivity Scale which is scored as follows: 0 Subject does not respond to air stimulus, 1. Subject responds to air stimulus but does not request discontinuation of stimulus 2. Subject responds to air stimulus and requests discontinuation or moves from stimulus 3. Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Muhammad Hasan Hameed, BDS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% fluoride varnish, 8% arginine containing paste and Self-adhesive resin in people with Dentine Hypersensitivity, run by Aga Khan University 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Jun 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robia Ghafoor, BDS,FCPS (02133106467 ext. 6467, robia.ghafoor@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of hypersensitivity (time frame: Reduction of hypersensitivity will be assessed at 2 weeks and 4 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 29 Jun 2018.