Dentin SensitivityPhase 4NCT02895321
Nano-hydroxyapatite With Potassium Nitrate in the Therapy of the Dental Sensitivity
A Phase 4 study testing Cavex Bite&White ExSense and Colgate, Protection Caries in people with Dentin Sensitivity, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
The chief aim of this study is to evaluate the difference in tooth sensitivity after having used a gel containing nano - hydroxyapatite and potassium nitrate This randomized double-blind clinical study is designed to compare the efficacy in reducing dentin hypersensitivity of a toothpaste gel containing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Cavex Bite&White ExSense and Colgate, Protection Caries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Sep 2016
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will be considered suitable for the study if they had sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine.
Who cannot join
- Teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study.
- Professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
- Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy of Nano-hydroxyapatite Combined With the Potassium Nitrate for the Treatment of Dental Sensitivity
The chief aim of this study is to evaluate the difference in tooth sensitivity after having used a gel containing nano - hydroxyapatite and potassium nitrate
This randomized double-blind clinical study is designed to compare the efficacy in reducing dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium nitrate (Cavex Bite \& White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste ( Colgate, Protection Caries, Palmolive SPA ).
Read more
Specific objectives :
To evaluate through standardized tests the dental sensitivity before and after the application of toothpastes; To compare the variations of dental sensitivity test and control groups.
Safety:
determination of adverse reactions, such as increased tooth pain and changes in the oral mucosa after application of the materials.
Read the detailed description
Study Design
The study will be a clinical randomized double-blind trial monocentric.
The sample will be divided into three groups with 35 patients each one.
TREATMENTS NOT ALLOWED
Patients enrolled in the study should not be submitted, for the whole duration of the trial, to local and systemic treatments for dentine hypersensitivity.
Randomization
The randomization process shall be made using a table randomly generated by a computer. The researchers will not be involved in the randomization process.
Data Recording
The study involves the assessment of the following parameters:
During the first visit, data on the overall health and patient's mouth will be collected. All subjects, once included in the study, will receive scaling and polishing treatments.
All these patients will be visited the initial day, once again after 15 days, then after four weeks and eight weeks (end of follow-up). Each subject will be evaluated by the same dentist throughout the course of the trial. During each visit, only the hypersensitive teeth (selected in the beginning of the trial) will be evaluated, so that a minimum of two to a maximum of four sensitive teeth are stimulated by the means of tactile tests and with air spray test.
Tactile test: a sharp dental explorer (EXD 11-12, Hu-Friedy, Chicago, IL, USA) will be dragged on the vestibular side of each tooth, perpendicular to the long axis with a constant force. The test will be repeated three times before recording a score.
Tests air spray: a jet of air will be directed towards the affected tooth area for 1 second from a distance of 10 mm, using a standard air-water syringe, while the adjacent teeth will be isolated with cotton.
The tests with stimuli will be applied in the order previously indicated, with a break of 5 minutes between applications of different stimuli. For tests with stimuli, subjects' responses will be recorded using the following scale:
- 0 - No significant discomfort or awareness of the stimulus;
- 1 - Nuisance, but not acute pain;
- 2 - Acute pain during the application of the stimulus;
- 3 - Acute pain during and after the application of the stimulus.
At each time, a score will be given according to the sensation of pain felt by the patient using a numeric categorical scale with 0-10 parameters (VAS).
Withdrawal of Consent: The patient may at any time withdraw his consent to continue the study. Exit criteria are at the discretion of the researcher: patients who do not show the controls will be excluded from evaluation.
The following dental materials were used following the manufacturers' instructions:
- Cavex Bite\&White ExSense (Cavex Holland BV, RW Haarlem, The Netherlands), a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
- Colgate Protection Caries (Palmolive SPA), a fluoride-based gel toothpaste.
- Placebo gel toothpaste (Baroniestraat, Amsterdam, The Netherlands), a glycerin and water gel.
- Conditions
- Dentin Sensitivity
- Being tested
- Cavex Bite&White ExSense, Colgate, Protection Caries, Placebo gel
- Keywords
- nano-hydroxyapatite, potassium nitrate
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavex Bite&White ExSenseOther
a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
Colgate, Protection CariesOther
a fluorine-based toothpaste gels
Placebo gelOther
a glycerin and water gel
| Study group | Role | What they receive |
|---|---|---|
| Patients with dentin hypersensitivity | Experimental | Patients with evident clinical signs of dentin hypersensitivity. The following dental materials will be used following the manufacturers' instructions: Cavex Bite\&White ExSense and Colgate Protection Caries and Placebo gel.
In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.
The effectiveness will be evaluated: immediately after application and after 2, 4, 8 weeks. Receives: Other: Cavex Bite&White ExSense; Other: Colgate, Protection Caries; Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment
The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.
Measured: baseline, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dentin 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Egle Milia, Università degli Studi di Sassari
- Investigators
- Egle Milia, Prof, Principal investigator, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895321
- Sponsor's protocol ID
- DH 2362CE
- Status last verified
- Oct 2016
- First submitted
- 4 Aug 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Not a plan for data sharing has been established. But, for anyone researcher would like to have this information, simply they may request them to us directly.
Publications
Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.
PubMed 22891890Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.
PubMed 25609032Vano M, Derchi G, Barone A, Genovesi A, Covani U. Tooth bleaching with hydrogen peroxide and nano-hydroxyapatite: a 9-month follow-up randomized clinical trial. Int J Dent Hyg. 2015 Nov;13(4):301-7. doi: 10.1111/idh.12123. Epub 2015 Jan 20.
PubMed 25600272Vano M, Derchi G, Barone A, Covani U. Effectiveness of nano-hydroxyapatite toothpaste in reducing dentin hypersensitivity: a double-blind randomized controlled trial. Quintessence Int. 2014 Sep;45(8):703-11. doi: 10.3290/j.qi.a32240.
PubMed 25019114
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of Nano-hydroxyapatite Combined With the Potassium Nitrate for the Treatment of Dental Sensitivity
- ClinicalTrials.gov ID
- NCT02895321
- Acronym / sponsor ID
- DH 2362CE
- Conditions
- Dentin Sensitivity
- Keywords
- nano-hydroxyapatite, potassium nitrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Sep 2016 (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.
The chief aim of this study is to evaluate the difference in tooth sensitivity after having used a gel containing nano - hydroxyapatite and potassium nitrate
This randomized double-blind clinical study is designed to compare the efficacy in reducing dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium nitrate (Cavex Bite \& White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste ( Colgate, Protection Caries, Palmolive SPA ).
Specific objectives :
To evaluate through standardized tests the dental sensitivity before and after the application of toothpastes; To compare the variations of dental sensitivity test and control groups.
Safety:
determination of adverse reactions, such as increased tooth pain and changes in the oral mucosa after application of the materials.
Detailed description
Study Design
The study will be a clinical randomized double-blind trial monocentric.
The sample will be divided into three groups with 35 patients each one.
TREATMENTS NOT ALLOWED
Patients enrolled in the study should not be submitted, for the whole duration of the trial, to local and systemic treatments for dentine hypersensitivity.
Randomization
The randomization process shall be made using a table randomly generated by a computer. The researchers will not be involved in the randomization process.
Data Recording
The study involves the assessment of the following parameters:
During the first visit, data on the overall health and patient's mouth will be collected. All subjects, once included in the study, will receive scaling and polishing treatments.
All these patients will be visited the initial day, once again after 15 days, then after four weeks and eight weeks (end of follow-up). Each subject will be evaluated by the same dentist throughout the course of the trial. During each visit, only the hypersensitive teeth (selected in the beginning of the trial) will be evaluated, so that a minimum of two to a maximum of four sensitive teeth are stimulated by the means of tactile tests and with air spray test.
Tactile test: a sharp dental explorer (EXD 11-12, Hu-Friedy, Chicago, IL, USA) will be dragged on the vestibular side of each tooth, perpendicular to the long axis with a constant force. The test will be repeated three times before recording a score.
Tests air spray: a jet of air will be directed towards the affected tooth area for 1 second from a distance of 10 mm, using a standard air-water syringe, while the adjacent teeth will be isolated with cotton.
The tests with stimuli will be applied in the order previously indicated, with a break of 5 minutes between applications of different stimuli. For tests with stimuli, subjects' responses will be recorded using the following scale:
- 0 - No significant discomfort or awareness of the stimulus;
- 1 - Nuisance, but not acute pain;
- 2 - Acute pain during the application of the stimulus;
- 3 - Acute pain during and after the application of the stimulus.
At each time, a score will be given according to the sensation of pain felt by the patient using a numeric categorical scale with 0-10 parameters (VAS).
Withdrawal of Consent: The patient may at any time withdraw his consent to continue the study. Exit criteria are at the discretion of the researcher: patients who do not show the controls will be excluded from evaluation.
The following dental materials were used following the manufacturers' instructions:
- Cavex Bite\&White ExSense (Cavex Holland BV, RW Haarlem, The Netherlands), a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
- Colgate Protection Caries (Palmolive SPA), a fluoride-based gel toothpaste.
- Placebo gel toothpaste (Baroniestraat, Amsterdam, The Netherlands), a glycerin and water gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dentin hypersensitivity | Experimental | Other: Cavex Bite&White ExSense, Other: Colgate, Protection Caries, Other: Placebo gelPatients with evident clinical signs of dentin hypersensitivity. The following dental materials will be used following the manufacturers' instructions: Cavex Bite\&White ExSense and Colgate Protection Caries and Placebo gel. In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups. The effectiveness will be evaluated: immediately after application and after 2, 4, 8 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be considered suitable for the study if they had sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine.
Key exclusion criteria (3 listed)
- Teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study.
- Professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
- Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).
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 |
|---|---|---|
| Cavex Bite&White ExSensea water-based mint aroma gel containing hydroxyapatite and potassium nitrate. | Other | Patients with dentin hypersensitivity |
| Colgate, Protection Cariesa fluorine-based toothpaste gels | Other | Patients with dentin hypersensitivity |
| Placebo gela glycerin and water gel | Other | Patients with dentin hypersensitivity |
Primary outcome
Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment
Time frame: baseline, 4 weeks, and 8 weeks
The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.
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 26 Oct 2016.
- Background: PubMed 22891890Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.
- Background: PubMed 25609032Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.
- Background: PubMed 25600272Vano M, Derchi G, Barone A, Genovesi A, Covani U. Tooth bleaching with hydrogen peroxide and nano-hydroxyapatite: a 9-month follow-up randomized clinical trial. Int J Dent Hyg. 2015 Nov;13(4):301-7. doi: 10.1111/idh.12123. Epub 2015 Jan 20.
- Background: PubMed 25019114Vano M, Derchi G, Barone A, Covani U. Effectiveness of nano-hydroxyapatite toothpaste in reducing dentin hypersensitivity: a double-blind randomized controlled trial. Quintessence Int. 2014 Sep;45(8):703-11. doi: 10.3290/j.qi.a32240.
- Individual participant dataSharing planned: No. Not a plan for data sharing has been established. But, for anyone researcher would like to have this information, simply they may request them to us directly.
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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.
Egle Milia, Prof principal investigator
Università degli Studi di Sassari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cavex Bite&White ExSense and Colgate, Protection Caries in people with Dentin Sensitivity, run by Università degli Studi di Sassari at 1 site in Italy.
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 3 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 26 Oct 2016. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment (time frame: baseline, 4 weeks, and 8 weeks). 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 NCT02895321, which also lists 4 linked publications.
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 26 Oct 2016.