Dentin SensitivityNCT02770573
Use of Biomaterials as Desensitizer Agents
A study testing Cavex Bite&White ExSense, Kuraray Teethmate™ Desensitizer and Ghimas Dentin Desensitizer in people with Dentin Sensitivity, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity. Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite\&White ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin… 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, Kuraray Teethmate™ Desensitizer and Ghimas Dentin Desensitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Dec 2017
- 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 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: Long-term Response of Three Biomaterials Used as Desensitizer Agents Under Oral Environmental Exposure.
Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity.
Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite\&White ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).
Read the detailed description
Participants The study is designed as randomized clinical trial. The participants will be selected from the regular attenders of the Dental Clinic in the University of Sassari, Italy.
Inclusion criteria:
- patients will be considered suitable for the study if they have sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine;
Exclusion criteria:
- 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).
Randomization Using a computer program (Excel 2010 for Mac OsX), the randomization will be carried on using an individual basis.
Clinical procedure A full medical and dental history will be taken and all the teeth will be carefully examined to confirm the diagnosis of DH. The experience of dentinal hypersensitivity and how this has affected the quality of life of the patients will be evaluated through a specific questionnaire. The nature and scope of the study will be explained and informed consent will be obtained.
A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste, soft tooth- brush and oral hygiene instructions will be also provided in order to have standardized habits during the period of the study.
A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste (Biorepair, Coswell), a soft toothbrush (Oral-B Sensitive Advantage, Procter \& Gamble) and oral hygiene instructions were also provided. The level of sensitivity experienced by each patient was considered as independent of the position of the hypersensitive tooth in the oral cavity. The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology described in our previous study. The pain experience was measured using a VAS graded from 1 to 10. The pain stimulus was given by one examiner with the same equipment yielding similar air pressure each time, while another one performed the treatments.
Teeth will be randomly assigned to three groups (N= per group) for the treatment with the three desensitizing agents.
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.
- Kuraray Teethmate™ Desensitizer (Kuraray Noritake Dental, Osaka, Japan), Calcium-Phosphate-based powder and a liquid mainly water-based.
- Ghimas Dentin Desensitizer (Ghimas, Bologna, Italy), a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.
- Conditions
- Dentin Sensitivity
- Being tested
- Cavex Bite&White ExSense, Kuraray Teethmate™ Desensitizer, Ghimas Dentin Desensitizer
- Keywords
- nano-hydroxyapatite
- 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.
Kuraray Teethmate™ DesensitizerOther
Calcium-Phosphate-based powder and a liquid mainly water-based.
Ghimas Dentin DesensitizerOther
a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.
| 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; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer.
In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.
The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks. Receives: Other: Cavex Bite&White ExSense; Other: Kuraray Teethmate™ Desensitizer; Other: Ghimas Dentin Desensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change of dentinal hypersensitivity after 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: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT02770573
- Sponsor's protocol ID
- DH 2304/CE
- Status last verified
- Apr 2017
- First submitted
- 11 May 2016
- Last updated
- 20 Apr 2017
- 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 25609032
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Response of Three Biomaterials Used as Desensitizer Agents Under Oral Environmental Exposure.
- ClinicalTrials.gov ID
- NCT02770573
- Acronym / sponsor ID
- DH 2304/CE
- Conditions
- Dentin Sensitivity
- Keywords
- nano-hydroxyapatite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 May 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.
Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity.
Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite\&White ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).
Detailed description
Participants The study is designed as randomized clinical trial. The participants will be selected from the regular attenders of the Dental Clinic in the University of Sassari, Italy.
Inclusion criteria:
- patients will be considered suitable for the study if they have sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine;
Exclusion criteria:
- 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).
Randomization Using a computer program (Excel 2010 for Mac OsX), the randomization will be carried on using an individual basis.
Clinical procedure A full medical and dental history will be taken and all the teeth will be carefully examined to confirm the diagnosis of DH. The experience of dentinal hypersensitivity and how this has affected the quality of life of the patients will be evaluated through a specific questionnaire. The nature and scope of the study will be explained and informed consent will be obtained.
A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste, soft tooth- brush and oral hygiene instructions will be also provided in order to have standardized habits during the period of the study.
A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste (Biorepair, Coswell), a soft toothbrush (Oral-B Sensitive Advantage, Procter \& Gamble) and oral hygiene instructions were also provided. The level of sensitivity experienced by each patient was considered as independent of the position of the hypersensitive tooth in the oral cavity. The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology described in our previous study. The pain experience was measured using a VAS graded from 1 to 10. The pain stimulus was given by one examiner with the same equipment yielding similar air pressure each time, while another one performed the treatments.
Teeth will be randomly assigned to three groups (N= per group) for the treatment with the three desensitizing agents.
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.
- Kuraray Teethmate™ Desensitizer (Kuraray Noritake Dental, Osaka, Japan), Calcium-Phosphate-based powder and a liquid mainly water-based.
- Ghimas Dentin Desensitizer (Ghimas, Bologna, Italy), a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.
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: Kuraray Teethmate™ Desensitizer, Other: Ghimas Dentin DesensitizerPatients with evident clinical signs of dentin hypersensitivity The following dental materials will be used following the manufacturers' instructions: Cavex Bite\&White ExSense; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer. In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups. The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 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 |
| Kuraray Teethmate™ DesensitizerCalcium-Phosphate-based powder and a liquid mainly water-based. | Other | Patients with dentin hypersensitivity |
| Ghimas Dentin Desensitizera fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite. | Other | Patients with dentin hypersensitivity |
Primary outcome
Evaluation of change of dentinal hypersensitivity after treatment
Time frame: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- 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.
- Effectiveness of nano-hydroxyapatite toothpaste in reducing dentin hypersensitivity: a double-blind randomized controlled trial.Link provided by the sponsor.
- 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.
Related trials for Dentin Sensitivity
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
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
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 study testing Cavex Bite&White ExSense, Kuraray Teethmate™ Desensitizer and Ghimas Dentin Desensitizer 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. 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.
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?
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 dentinal hypersensitivity after treatment (time frame: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).). 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 NCT02770573, which also lists 2 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 20 Apr 2017.