Dentinal HypersensitivityNCT04091256
Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste
A study testing Single arm clinical study in people with Dentinal Hypersensitivity, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8 weeks of treatment Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- Single arm clinical study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Jan 2019to 26 Aug 2019
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All male and female subjects 20 to 70 years of age
- All subjects in good health
- All subjects must have 2 teeth with DH, only incisors, canine and premolars were included with the exposed cervical dentin (facial surfaces).
- All participants of the study having Schiff Sensitivity Scale score of 2 \& 3
Who cannot join
- Subjects with deep carious teeth, defective restorations
- Any pathological lesion
- Periodontal disease, mobile teeth, cracked enamel, orthodontic appliances,
- Periodontal pockets >4mm
- Subjects using pain control medicines, sensitive toothpaste
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry Qassim University
Buraidah, Al Qassim, 51452
About this study
Official title: Evaluate Efficacy of Desensitizing Toothpaste Containing Zinc-carbonate Hydroxyapatite Before and After: A 8 Week Clinical Study
The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8 weeks of treatment
Read the detailed description
This clinical study design is an 8-week single center, before and after use of desensitize dentifrice. This study will conducted in the College of Dentistry Qassim University. 72 patients surfing from DH, include in the study fulfill the inclusion criteria. All subjects 20 to 70 years of age in good health, and must have 2 teeth with DH, will be included in this study. Screening will be performed for the selection of patients, which fulfill the inclusion criteria. Baseline data will be recorded and Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS).
Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) described 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
- Conditions
- Dentinal Hypersensitivity
- Being tested
- Single arm clinical study
- Keywords
- Biorepair sensitive toothpaste, Clinical trial, Dentinal Hypersensitivity, Schiff Sensitivity Scale, Zinc-carbonate hydroxyapatite nanocrystals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single arm clinical studyOther
Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Clinical trials with a single arm | Experimental | : Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks. Receives: Other: Single arm clinical study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks.
This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 4 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) 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.
Measured: 4 Weeks
Secondary outcomes (1)
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks
This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 8 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) 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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start18 Jan 2019
- Primary completion29 Jul 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal 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
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Khalil Khan, Qassim University
- Investigators
- Dhafer Al Asmari, Board, Principal investigator, Qassim UniversityMuhammad K Khan, PhD, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091256
- Sponsor's protocol ID
- ST/55/2019
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Efficacy of Desensitizing Toothpaste Containing Zinc-carbonate Hydroxyapatite Before and After: A 8 Week Clinical Study
- ClinicalTrials.gov ID
- NCT04091256
- Acronym / sponsor ID
- ST/55/2019
- Conditions
- Dentinal Hypersensitivity
- Keywords
- Biorepair sensitive toothpaste, Clinical trial, Dentinal Hypersensitivity, Schiff Sensitivity Scale, Zinc-carbonate hydroxyapatite nanocrystals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 16 Sep 2019 (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.
The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8 weeks of treatment
Detailed description
This clinical study design is an 8-week single center, before and after use of desensitize dentifrice. This study will conducted in the College of Dentistry Qassim University. 72 patients surfing from DH, include in the study fulfill the inclusion criteria. All subjects 20 to 70 years of age in good health, and must have 2 teeth with DH, will be included in this study. Screening will be performed for the selection of patients, which fulfill the inclusion criteria. Baseline data will be recorded and Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS).
Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) described 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Clinical trials with a single arm | Experimental | Other: Single arm clinical study: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All male and female subjects 20 to 70 years of age
- All subjects in good health
- All subjects must have 2 teeth with DH, only incisors, canine and premolars were included with the exposed cervical dentin (facial surfaces).
- All participants of the study having Schiff Sensitivity Scale score of 2 \& 3
Key exclusion criteria (6 listed)
- Subjects with deep carious teeth, defective restorations
- Any pathological lesion
- Periodontal disease, mobile teeth, cracked enamel, orthodontic appliances,
- Periodontal pockets >4mm
- Subjects using pain control medicines, sensitive toothpaste
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 |
|---|---|---|
| Single arm clinical studyParticipants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks. | Other | Clinical trials with a single arm |
Primary outcome
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks.
Time frame: 4 Weeks
This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 4 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) 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.
1 secondary outcome
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks
Time frame: 8 Weeks
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 16 Sep 2019.
Related trials for Dentinal Hypersensitivity
RecruitingPhase 3
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Dentinal Sensitivity, Dentinal Hypersensitivity
Not yet recruitingPhase 2/3
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
Not yet recruiting
Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT
Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
Not yet recruiting
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
Dentinal Hypersensitivity
Not yet recruiting
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
Dentistry, Desensitization
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.
Dhafer Al Asmari, Board principal investigator
Qassim University
Muhammad K Khan, PhD principal investigator
Qassim 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 Single arm clinical study in people with Dentinal Hypersensitivity, run by Qassim University at 1 site in Saudi Arabia.
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 4 inclusion and 6 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 16 Sep 2019. 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 Saudi Arabia. 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 (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks. (time frame: 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 16 Sep 2019.