Dentin SensitivityNCT06216262
Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity
A study testing Arginine, Novamin and Propolis in people with Dentin Sensitivity, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
Dentin sensitivity is one of the most common problems in society and affects the quality of life related to oral health. Agents such as toothpaste, mouthwash, and dental cream are home-type desensitizing agents used as the first step in the treatment of dentin hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Arginine, Novamin and Propolis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 23 Aug 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-70 years old
- General health condition is good
- Individuals with sensitivity in 2 or more non-adjacent teeth
Who cannot join
- Pregnant or breastfeeding women
- Advanced periodontal diseases
- Chronic diseases that may affect the study results
- Major oral pathologies
- Use of anticonvulsant, antihistamine, antidepressant, sedative, tranquilizer medication
- Use of desensitizing paste in the last 3 months
- Individuals who have been treated for periodontal disease in the last 12 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University Faculty of Dentistry
Çanakkale
About this study
Dentin sensitivity is one of the most common problems in society and affects the quality of life related to oral health. Agents such as toothpaste, mouthwash, and dental cream are home-type desensitizing agents used as the first step in the treatment of dentin hypersensitivity. A total of 180 individuals with dentin sensitivity will be included in the study and the individuals will be randomly divided into 6 groups. Individuals in the 1st Group will be given arginine-containing toothpaste, individuals in the 2nd Group will be given novamin-containing toothpaste, individuals in the 3rd Group will be given propolis-containing toothpaste, individuals in the 4th Group will be given casein phosphopeptide amorphous calcium phosphate-containing dental cream, and individuals in the 5th Group will be given mouthwash containing potassium nitrate. Classic toothpaste with 1450 ppm fluoride will be distributed to individuals in the control group, which is the 6th group. The Dentin Hypersensitivity Experience Questionnaire (DHEQ-15), consisting of 15 questions, will be used to evaluate dentin sensitivity. Visual Analogue Scale (VAS) will be used to determine the individual's pain score in dentin sensitivity, and the individual will be asked to score the intensity of pain experienced between 0-10 points. Finally, in the evaluation of dentin sensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second, and the Schiff Sensitivity Scale score will be determined through clinical examination. A score between 0 and 3 will be determined by the dentist according to the patient's response to the air stimulus. The effectiveness of the home-use desensitizing agents used in the treatment of dentin hypersensitivity was evaluated with DHEQ-15, VAS and Schiff Sensitivity Scale; Baseline, 4th and 8th week scores will be compared.
- Conditions
- Dentin Sensitivity
- Being tested
- Control group, Arginine, Novamin, Propolis, Casein Phosphopeptide Amorphous Calcium Phosphate
- Keywords
- Arginine, Novamin, Propolis
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Brushing teeth twice a day for 8 weeks
ArginineOther
Brushing teeth twice a day for 8 weeks
NovaminOther
Brushing teeth twice a day for 8 weeks
PropolisOther
Brushing teeth twice a day for 8 weeks
Casein Phosphopeptide Amorphous Calcium PhosphateOther
Following the procedure in the control group, it is applied to the tooth surface once a day for 3 minutes before going to bed at night for 8 weeks
Potassium NitrateOther
Following the procedure in the control group, mouthwash twice a day in the morning and evening for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 1450 ppm fluoride toothpaste Receives: Other: Control group |
| Arginine | Active comparator | toothpaste containing arginine Receives: Other: Arginine |
| Novamin | Active comparator | toothpaste containing novamin Receives: Other: Novamin |
| Propolis | Active comparator | toothpaste containing propolis Receives: Other: Propolis |
| Casein Phosphopeptide Amorphous Calcium Phosphate | Active comparator | Dental cream containing casein phosphopeptide amorphous calcium phosphate Receives: Other: Control group; Other: Casein Phosphopeptide Amorphous Calcium Phosphate |
| Potassium Nitrate | Active comparator | mouthwash containing potassium nitrate Receives: Other: Control group; Other: Potassium Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)
Dentin Hypersensitivity Experience Questionnaire-15 (DHEQ-15) is a 7-point Likert scale form consisting of 15 questions used to evaluate dentin sensitivity, with answers ranging from 'strongly agree' to 'strongly disagree'.
Measured: for 8 weeks (initially, 4 weeks and 8 weeks)
Visual Analogue Scale (VAS)
VAS is a scale in which the individual evaluates the pain level between 0 (no hurt) and 10 (hurts worst).
Measured: for 8 weeks (initially, 4 weeks and 8 weeks)
Schiff Sensitivity Scale
In the evaluation of dentin hypersensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second during a clinical examination and the Schiff Sensitivity Scale score will be determined.
0: subject does not respond to air stimulus
- subject responds to air stimulus but does not request discontinuaiton of stimulus
- subject responds to air stimulus and requests discontinuaiton or moves from stimulus
- subject responds to the air stimulus, considers stimulus to be painful and requests discontinuaiton of the stimulus
Measured: for 8 weeks (initially, 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 posted22 Jan 2024
- Study start1 Mar 2024
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem AYAN, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216262
- Sponsor's protocol ID
- TSA-2023-4535
- Status last verified
- Aug 2024
- First submitted
- 26 Dec 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.
PubMed 31640741Baker SR, Gibson BJ, Sufi F, Barlow A, Robinson PG. The Dentine Hypersensitivity Experience Questionnaire: a longitudinal validation study. J Clin Periodontol. 2014 Jan;41(1):52-9. doi: 10.1111/jcpe.12181. Epub 2013 Nov 6.
PubMed 24117696Basaran S, Celik C. Turkish Adaptation of Dentine Hypersensitivity Experience Questionnaire (DHEQ). Community Dent Health. 2018 Mar 1;35(1):47-51. doi: 10.1922/CDH_4151Basaran05.
PubMed 29369544Ayan G, Msmall i, Ukrainianssmall i, Ukrainianllsmall i, Ukrainian T, Buldur M. Home-use agents in the treatment of dentin hypersensitivity: clinical effectiveness evaluation with different measurement methods. Clin Oral Investig. 2025 Jan 15;29(1):63. doi: 10.1007/s00784-025-06155-1.
PubMed 39810073
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06216262
- Acronym / sponsor ID
- TSA-2023-4535
- Conditions
- Dentin Sensitivity
- Keywords
- Arginine, Novamin, Propolis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 22 Jan 2024 (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.
Dentin sensitivity is one of the most common problems in society and affects the quality of life related to oral health. Agents such as toothpaste, mouthwash, and dental cream are home-type desensitizing agents used as the first step in the treatment of dentin hypersensitivity. A total of 180 individuals with dentin sensitivity will be included in the study and the individuals will be randomly divided into 6 groups. Individuals in the 1st Group will be given arginine-containing toothpaste, individuals in the 2nd Group will be given novamin-containing toothpaste, individuals in the 3rd Group will be given propolis-containing toothpaste, individuals in the 4th Group will be given casein phosphopeptide amorphous calcium phosphate-containing dental cream, and individuals in the 5th Group will be given mouthwash containing potassium nitrate. Classic toothpaste with 1450 ppm fluoride will be distributed to individuals in the control group, which is the 6th group. The Dentin Hypersensitivity Experience Questionnaire (DHEQ-15), consisting of 15 questions, will be used to evaluate dentin sensitivity. Visual Analogue Scale (VAS) will be used to determine the individual's pain score in dentin sensitivity, and the individual will be asked to score the intensity of pain experienced between 0-10 points. Finally, in the evaluation of dentin sensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second, and the Schiff Sensitivity Scale score will be determined through clinical examination. A score between 0 and 3 will be determined by the dentist according to the patient's response to the air stimulus. The effectiveness of the home-use desensitizing agents used in the treatment of dentin hypersensitivity was evaluated with DHEQ-15, VAS and Schiff Sensitivity Scale; Baseline, 4th and 8th week scores will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control group1450 ppm fluoride toothpaste |
| Arginine | Active comparator | Other: Argininetoothpaste containing arginine |
| Novamin | Active comparator | Other: Novamintoothpaste containing novamin |
| Propolis | Active comparator | Other: Propolistoothpaste containing propolis |
| Casein Phosphopeptide Amorphous Calcium Phosphate | Active comparator | Other: Control group, Other: Casein Phosphopeptide Amorphous Calcium PhosphateDental cream containing casein phosphopeptide amorphous calcium phosphate |
| Potassium Nitrate | Active comparator | Other: Control group, Other: Potassium Nitratemouthwash containing potassium nitrate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18-70 years old
- General health condition is good
- Individuals with sensitivity in 2 or more non-adjacent teeth
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women
- Advanced periodontal diseases
- Chronic diseases that may affect the study results
- Major oral pathologies
- Use of anticonvulsant, antihistamine, antidepressant, sedative, tranquilizer medication
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 |
|---|---|---|
| Control groupBrushing teeth twice a day for 8 weeks | Other | Casein Phosphopeptide Amorphous Calcium Phosphate, Control group, Potassium Nitrate |
| ArginineBrushing teeth twice a day for 8 weeks | Other | Arginine |
| NovaminBrushing teeth twice a day for 8 weeks | Other | Novamin |
| PropolisBrushing teeth twice a day for 8 weeks | Other | Propolis |
| Casein Phosphopeptide Amorphous Calcium PhosphateFollowing the procedure in the control group, it is applied to the tooth surface once a day for 3 minutes before going to bed at night for 8 weeks | Other | Casein Phosphopeptide Amorphous Calcium Phosphate |
| Potassium NitrateFollowing the procedure in the control group, mouthwash twice a day in the morning and evening for 8 weeks | Other | Potassium Nitrate |
Primary outcome
Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)
Time frame: for 8 weeks (initially, 4 weeks and 8 weeks)
Dentin Hypersensitivity Experience Questionnaire-15 (DHEQ-15) is a 7-point Likert scale form consisting of 15 questions used to evaluate dentin sensitivity, with answers ranging from 'strongly agree' to 'strongly disagree'.
Visual Analogue Scale (VAS)
Time frame: for 8 weeks (initially, 4 weeks and 8 weeks)
VAS is a scale in which the individual evaluates the pain level between 0 (no hurt) and 10 (hurts worst).
Schiff Sensitivity Scale
Time frame: for 8 weeks (initially, 4 weeks and 8 weeks)
In the evaluation of dentin hypersensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second during a clinical examination and the Schiff Sensitivity Scale score will be determined. 0: subject does not respond to air stimulus 1. subject responds to air stimulus but does not request discontinuaiton of stimulus 2. subject responds to air stimulus and requests discontinuaiton or moves from stimulus 3. subject responds to the air stimulus, considers stimulus to be painful and requests discontinuaiton of the stimulus
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 Aug 2024.
- Background: PubMed 31640741Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.
- Background: PubMed 24117696Baker SR, Gibson BJ, Sufi F, Barlow A, Robinson PG. The Dentine Hypersensitivity Experience Questionnaire: a longitudinal validation study. J Clin Periodontol. 2014 Jan;41(1):52-9. doi: 10.1111/jcpe.12181. Epub 2013 Nov 6.
- Background: PubMed 29369544Basaran S, Celik C. Turkish Adaptation of Dentine Hypersensitivity Experience Questionnaire (DHEQ). Community Dent Health. 2018 Mar 1;35(1):47-51. doi: 10.1922/CDH_4151Basaran05.
- Derived from this study: PubMed 39810073Ayan G, Msmall i, Ukrainianssmall i, Ukrainianllsmall i, Ukrainian T, Buldur M. Home-use agents in the treatment of dentin hypersensitivity: clinical effectiveness evaluation with different measurement methods. Clin Oral Investig. 2025 Jan 15;29(1):63. doi: 10.1007/s00784-025-06155-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine, Novamin and Propolis in people with Dentin Sensitivity, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 26 Aug 2024. 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 Turkey (Türkiye). 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?
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?
Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15) (time frame: for 8 weeks (initially, 4 weeks and 8 weeks)). The study lists 3 primary outcomes in all. 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 NCT06216262, 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 Aug 2024.