Dentine HypersensitivityNCT06197555
Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes
A study testing Sodium Monofluorophosphate, Stannous Fluoride and Nano-Hydroxyapatite in people with Dentine Hypersensitivity, run by Altinbas University at 1 site in Turkey (Türkiye).
Trial summary
Dentin hypersensitivity is a common problem in society. Untreated hypersensitivity affects the patient's quality of life, complicates plaque control and increases the risk of caries and periodontal disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Sodium Monofluorophosphate, Stannous Fluoride and Nano-Hydroxyapatite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 20 Feb 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dentin hypersensitivity complaints
- Systemically healthy
- Not during pregnancy \& lactation
- No sensitivity treatment in the last 6 months
- Forty-eight patients with positive response to VAS and Schiff tests were included.
Who cannot join
- People who have;
- Any systemic disease
- Take regular medication for any other reason
- Undergone periodontal surgery within the last 6 months,
- History of allergy to toothpaste materials,
- Active caries, restoration and/or bridge on the sensitive tooth,
- Orthodontic appliances,
Trial locations and contacts
1 site in 1 country.
About this study
Dentin hypersensitivity is a common problem in society. Untreated hypersensitivity affects the patient's quality of life, complicates plaque control and increases the risk of caries and periodontal disease. This study aimed to evaluate the clinical efficacy of desensitizing toothpastes containing sodium fluoride, stannous fluoride, nano-hydroxyapatite, 8% arginine and calcium carbonate.
Fourty eight patients with at least two teeth with positive responses to air and mechanical stimulus were included in the study and were divided into four groups. Sodium fluoride (Colgate®, Cavity Protection) in group A, stannous fluoride (Oral B® Gum Calm \& Sensitivity) in group B, nano-hydroxyapatite (ApaCare®) in group C and 8% arginine and calcium carbonate combination in group D (Colgate® Sensitive Pro- ReliefTM) were used by the patients continuously for 16 weeks. Dentin hypersensitivity, by using VAS and Shiff scores and periodontal parameters were evaluated at baseline, 2nd week, 4th week and last 16th week.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Sodium Monofluorophosphate, Stannous Fluoride, Nano-Hydroxyapatite, 8% Arginine & Calcium Carbonate
- Keywords
- Dentin Hypersensitivity, Toothpaste, Fluoride, Arginine, 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.
Sodium MonofluorophosphateOther
Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.
Stannous FluorideOther
Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.
Nano-HydroxyapatiteOther
Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.
8% Arginine & Calcium CarbonateOther
Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Sodium Monofluorophosphate) | Active comparator | Dentifrice containing Sodium Monofluorophosphate, daily homecare usage Colgate®, Cavity Protection Receives: Other: Sodium Monofluorophosphate |
| Group B (Stannous Fluoride) | Active comparator | Dentifrice containing Stannous Fluoride, daily homecare usage Oral B®, Gum Calm \& Sensitivity Receives: Other: Stannous Fluoride |
| Group C (Nano-Hydroxyapatite) | Active comparator | Dentifrice containing Nano-Hydroxyapatite, daily homecare usage ApaCare® Receives: Other: Nano-Hydroxyapatite |
| Group D (8% Arginine & Calcium Carbonate) | Active comparator | Dentifrice containing 8% Arginine \& Calcium Carbonate, daily homecare usage Colgate®, Sensitive Pro-Relief Receives: Other: 8% Arginine & Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity Reduction
Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Baseline, 2nd week, 4th week, 16th week
Hypersensitivity Reduction
The Schiff Scale examiner covers the adjacent teeth on either side of the patient's hypersensitive tooth with his/her fingers. Air from the tip of the dental unit's air-water sprayer is applied to the cervical region of the hypersensitive tooth at a distance of approximately 1 cm for 1 second. The degree of hypersensitivity is scored according to the Schiff cold air sensitivity scale. Scoring :
Score 0: The individual does not respond to the stimulus. Score 1: The individual responds to the stimulus but does not request its termination. Score 2: The individual responds to the stimulus and requests its termination or moves to avoid the stimulus. Score 3: The individual responds to the stimulus, finds the stimulus painful and requests its termination. The pain persists for a few seconds after the stimulus is terminated.
Measured: Baseline, 2nd week, 4th week, 16th week
Secondary outcomes (4)
Clinical Periodontal Measurements
Probing depths (mm)
Measured: Baseline, 16th week
Clinical Periodontal Measurements
Clinical attachment levels (mm)
Measured: Baseline, 16th week
Clinical Periodontal Measurements
Plaque score (%),
Measured: Baseline, 16th week
Clinical Periodontal Measurements
Bleeding score (%)
Measured: Baseline, 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 May 2022
- Primary completion24 Dec 2022
- Study completion20 Feb 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevdenur GÜNENÇ, Altinbas University
- Investigators
- İlknur ÖZENCİ, Study chair, Altinbas UniversityŞebnem DİRİKAN İPÇİ, Study director, Altinbas UniversityGökser ÇAKAR, Study director, Altinbas UniversitySevdenur GÜNENÇ, Principal investigator, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197555
- Sponsor's protocol ID
- 2022/138
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes
- ClinicalTrials.gov ID
- NCT06197555
- Acronym / sponsor ID
- 2022/138
- Conditions
- Dentine Hypersensitivity
- Keywords
- Dentin Hypersensitivity, Toothpaste, Fluoride, Arginine, Nano-Hydroxyapatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 9 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 hypersensitivity is a common problem in society. Untreated hypersensitivity affects the patient's quality of life, complicates plaque control and increases the risk of caries and periodontal disease. This study aimed to evaluate the clinical efficacy of desensitizing toothpastes containing sodium fluoride, stannous fluoride, nano-hydroxyapatite, 8% arginine and calcium carbonate.
Fourty eight patients with at least two teeth with positive responses to air and mechanical stimulus were included in the study and were divided into four groups. Sodium fluoride (Colgate®, Cavity Protection) in group A, stannous fluoride (Oral B® Gum Calm \& Sensitivity) in group B, nano-hydroxyapatite (ApaCare®) in group C and 8% arginine and calcium carbonate combination in group D (Colgate® Sensitive Pro- ReliefTM) were used by the patients continuously for 16 weeks. Dentin hypersensitivity, by using VAS and Shiff scores and periodontal parameters were evaluated at baseline, 2nd week, 4th week and last 16th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (Sodium Monofluorophosphate) | Active comparator | Other: Sodium MonofluorophosphateDentifrice containing Sodium Monofluorophosphate, daily homecare usage Colgate®, Cavity Protection |
| Group B (Stannous Fluoride) | Active comparator | Other: Stannous FluorideDentifrice containing Stannous Fluoride, daily homecare usage Oral B®, Gum Calm \& Sensitivity |
| Group C (Nano-Hydroxyapatite) | Active comparator | Other: Nano-HydroxyapatiteDentifrice containing Nano-Hydroxyapatite, daily homecare usage ApaCare® |
| Group D (8% Arginine & Calcium Carbonate) | Active comparator | Other: 8% Arginine & Calcium CarbonateDentifrice containing 8% Arginine \& Calcium Carbonate, daily homecare usage Colgate®, Sensitive Pro-Relief |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dentin hypersensitivity complaints
- Systemically healthy
- Not during pregnancy \& lactation
- No sensitivity treatment in the last 6 months
- Forty-eight patients with positive response to VAS and Schiff tests were included.
Key exclusion criteria (7 listed)
- People who have;
- Any systemic disease
- Take regular medication for any other reason
- Undergone periodontal surgery within the last 6 months,
- History of allergy to toothpaste materials,
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 |
|---|---|---|
| Sodium MonofluorophosphateTest toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks. | Other | Group A (Sodium Monofluorophosphate) |
| Stannous FluorideTest toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks. | Other | Group B (Stannous Fluoride) |
| Nano-HydroxyapatiteTest toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks. | Other | Group C (Nano-Hydroxyapatite) |
| 8% Arginine & Calcium CarbonateTest toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks. | Other | Group D (8% Arginine & Calcium Carbonate) |
Primary outcome
Hypersensitivity Reduction
Time frame: Baseline, 2nd week, 4th week, 16th week
Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Hypersensitivity Reduction
Time frame: Baseline, 2nd week, 4th week, 16th week
The Schiff Scale examiner covers the adjacent teeth on either side of the patient's hypersensitive tooth with his/her fingers. Air from the tip of the dental unit's air-water sprayer is applied to the cervical region of the hypersensitive tooth at a distance of approximately 1 cm for 1 second. The degree of hypersensitivity is scored according to the Schiff cold air sensitivity scale. Scoring : Score 0: The individual does not respond to the stimulus. Score 1: The individual responds to the stimulus but does not request its termination. Score 2: The individual responds to the stimulus and requests its termination or moves to avoid the stimulus. Score 3: The individual responds to the stimulus, finds the stimulus painful and requests its termination. The pain persists for a few seconds after the stimulus is terminated.
4 secondary outcomes
Clinical Periodontal Measurements
Time frame: Baseline, 16th week
Clinical Periodontal Measurements
Time frame: Baseline, 16th week
Clinical Periodontal Measurements
Time frame: Baseline, 16th week
Clinical Periodontal Measurements
Time frame: Baseline, 16th week
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 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
İlknur ÖZENCİ study chair
Altinbas University
Şebnem DİRİKAN İPÇİ study director
Altinbas University
Gökser ÇAKAR study director
Altinbas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Monofluorophosphate, Stannous Fluoride and Nano-Hydroxyapatite in people with Dentine Hypersensitivity, run by Altinbas 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 5 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 9 Jan 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?
Hypersensitivity Reduction (time frame: Baseline, 2nd week, 4th week, 16th week). The study lists 2 primary outcomes in all. 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 9 Jan 2024.