Dentin HypersensitivityNCT07511530
Management of Dentinal Hypersensitivity Using Two Dentifrice Technologies
A study testing Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash and Lacalut White and Repair Toothpaste in people with Dentin Hypersensitivity and Tooth Discoloration, run by Prof. Mayyas Al-Remawi at 1 site in Jordan.
Trial summary
This study evaluates the effectiveness of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash in reducing tooth sensitivity and improving tooth whitening compared to Lacalut® White \& Repair toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Tooth Discoloration
- What is being tested?
- Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash and Lacalut White and Repair Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteJordan
- Study dates
- 18 Aug 2024to 31 Aug 2025
- 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
- Healthy male or female participants aged 18 to 65 years
- Individuals with mild to moderate tooth staining
- Individuals with self-reported tooth sensitivity to hot, cold, sweet, or acidic stimuli
- Ability and willingness to comply with all study procedures
- Provision of written informed consent
Who cannot join
- History of allergic reactions to any component of the study products
- Presence of clinically significant allergic disease
- Pregnant or lactating women
- Women of childbearing potential not using an acceptable method of contraception
- Individuals with severe tooth staining requiring professional treatment
- Individuals who have received recent treatment for tooth discoloration
- Individuals with severe periodontal disease requiring immediate intervention
- Individuals with significant dental conditions such as active caries, periodontal disease, or ongoing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Study to Evaluate the Efficacy of Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash in Tooth Whitening and Treating Tooth Sensitivity in a Control Group Using Standardized Methods and Criteria
This study evaluates the effectiveness of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash in reducing tooth sensitivity and improving tooth whitening compared to Lacalut® White \& Repair toothpaste. Participants will be randomly assigned to either the Scigates group or the Lacalut control group and will use the assigned product three times daily for 8 weeks. Tooth sensitivity and dental staining will be assessed at multiple time points using standardized clinical scales. Safety will also be monitored throughout the study.
Read the detailed description
This study is a randomized, parallel-group, controlled post-marketing clinical trial designed to evaluate the efficacy and safety of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash compared to Lacalut® White \& Repair toothpaste in reducing tooth sensitivity and improving tooth whitening.
Healthy adult participants aged 18 to 65 years with mild to moderate tooth staining and self-reported tooth sensitivity were enrolled and randomly assigned to either the test group, receiving Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash, or the control group, receiving Lacalut® White \& Repair toothpaste. Participants used the assigned product three times daily for a period of 8 weeks according to standardized instructions.
A total of 57 participants were enrolled. The study was conducted as an exploratory post-marketing investigation and was concluded at this sample size to provide preliminary estimates of treatment effects, variability, and feasibility, which may inform the design and statistical powering of future larger-scale confirmatory studies.
Efficacy was assessed using validated clinical measures. Tooth sensitivity was evaluated using the Schiff Cold Air Sensitivity Scale, and dental extrinsic staining was assessed using the Modified Lobene Stain Index. Assessments were conducted at baseline and at weeks 1, 2, 4, and 8 to monitor changes over time.
Safety was evaluated throughout the study by recording adverse events and conducting clinical assessments. Participants were instructed to avoid the use of other dental treatments during the study period unless approved by the investigator.
Data were analyzed using appropriate statistical methods, including parametric and non-parametric tests, with an intention-to-treat approach. The study was conducted in accordance with Good Clinical Practice guidelines and ethical principles outlined in the Declaration of Helsinki.
- Conditions
- Dentin Hypersensitivity, Tooth Discoloration
- Being tested
- Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash, Lacalut White and Repair Toothpaste
- Keywords
- Dentin Hypersensitivity, Tooth Discoloration, Tooth Whitening, Desensitizing Toothpaste, Oral Care Products, Schiff Sensitivity Scale, Lobene Stain Index, Dental Staining
- Medical subject headings
- Dentin Sensitivity, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and MouthwashDrug
Participants will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks by applying the product directly to the toothbrush and brushing for 2-3 minutes according to standardized instructions.
Lacalut White and Repair ToothpasteDrug
Participants will use Lacalut® White and Repair toothpaste three times daily for 8 weeks by applying the product directly to the toothbrush and brushing for 2-3 minutes according to standardized instructions.
| Study group | Role | What they receive |
|---|---|---|
| Scigates Toothpaste Group | Experimental | Participants assigned to this arm will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks according to standardized instructions. Receives: Drug: Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash |
| Lacalut Toothpaste Group | Active comparator | Participants assigned to this arm will use Lacalut® White \& Repair toothpaste three times daily for 8 weeks according to standardized instructions. Receives: Drug: Lacalut White and Repair Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Tooth Sensitivity
Tooth sensitivity will be assessed using the Schiff Cold Air Sensitivity Scale. This is a 4-point ordinal scale ranging from 0 to 3, where:
0 = No response to air stimulus (best outcome)
- = Response to air stimulus without request to discontinue
- = Response with request to discontinue or movement away
- = Painful response with request to discontinue (worst outcome)
Interpretation: Lower scores indicate less tooth sensitivity (better outcome), while higher scores indicate greater sensitivity (worse outcome).
Assessments will be performed at Baseline, Week 1, Week 2, Week 4, and Week 8.
Measured: Baseline, Week 1, Week 2, Week 4, and Week 8
Reduction in Dental Extrinsic Staining
Dental extrinsic staining will be assessed using the Modified Lobene Stain Index (MLSI). This index evaluates both extent and intensity of staining, each scored on a scale from 0 to 3:
Extent of Staining (0-3):
0 = No stain
- = Up to 1/3 of surface stained
- = 1/3 to 2/3 of surface stained
- = More than 2/3 of surface stained
Intensity of Staining (0-3):
0 = No stain
- = Light stain
- = Moderate stain
- = Heavy stain
Scores from extent and intensity (for specified teeth) are summed to generate a composite score, with a possible range from 0 to 12.
Interpretation: Lower scores indicate less staining (better outcome), while higher scores indicate more severe staining (worse outcome).
Stain assessment will be performed on the labial surface of the upper left central incisor and upper left canine (or right counterparts if needed) at Baseline, Week 1, Week 2, Week 4, and Week 8.
Measured: Baseline, Week 1, Week 2, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start18 Aug 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin 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
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Mayyas Al-Remawi
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Raed Alkhatib Dental Center, The Jordan Center for Pharmaceutical Research (JCPR)
- Responsible party
- Sponsor-investigator, Prof. Mayyas Al-Remawi, University of Petra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511530
- Sponsor's protocol ID
- MD-644/2021
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Study to Evaluate the Efficacy of Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash in Tooth Whitening and Treating Tooth Sensitivity in a Control Group Using Standardized Methods and Criteria
- ClinicalTrials.gov ID
- NCT07511530
- Acronym / sponsor ID
- MD-644/2021
- Conditions
- Dentin Hypersensitivity, Tooth Discoloration
- Keywords
- Dentin Hypersensitivity, Tooth Discoloration, Tooth Whitening, Desensitizing Toothpaste, Oral Care Products, Schiff Sensitivity Scale, Lobene Stain Index, Dental Staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Prof. Mayyas Al-RemawiUniversity, hospital or other
- Collaborators
- Dr. Raed Alkhatib Dental Center, The Jordan Center for Pharmaceutical Research (JCPR)
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 Apr 2026 (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.
This study evaluates the effectiveness of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash in reducing tooth sensitivity and improving tooth whitening compared to Lacalut® White \& Repair toothpaste. Participants will be randomly assigned to either the Scigates group or the Lacalut control group and will use the assigned product three times daily for 8 weeks. Tooth sensitivity and dental staining will be assessed at multiple time points using standardized clinical scales. Safety will also be monitored throughout the study.
Detailed description
This study is a randomized, parallel-group, controlled post-marketing clinical trial designed to evaluate the efficacy and safety of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash compared to Lacalut® White \& Repair toothpaste in reducing tooth sensitivity and improving tooth whitening.
Healthy adult participants aged 18 to 65 years with mild to moderate tooth staining and self-reported tooth sensitivity were enrolled and randomly assigned to either the test group, receiving Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash, or the control group, receiving Lacalut® White \& Repair toothpaste. Participants used the assigned product three times daily for a period of 8 weeks according to standardized instructions.
A total of 57 participants were enrolled. The study was conducted as an exploratory post-marketing investigation and was concluded at this sample size to provide preliminary estimates of treatment effects, variability, and feasibility, which may inform the design and statistical powering of future larger-scale confirmatory studies.
Efficacy was assessed using validated clinical measures. Tooth sensitivity was evaluated using the Schiff Cold Air Sensitivity Scale, and dental extrinsic staining was assessed using the Modified Lobene Stain Index. Assessments were conducted at baseline and at weeks 1, 2, 4, and 8 to monitor changes over time.
Safety was evaluated throughout the study by recording adverse events and conducting clinical assessments. Participants were instructed to avoid the use of other dental treatments during the study period unless approved by the investigator.
Data were analyzed using appropriate statistical methods, including parametric and non-parametric tests, with an intention-to-treat approach. The study was conducted in accordance with Good Clinical Practice guidelines and ethical principles outlined in the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scigates Toothpaste Group | Experimental | Drug: Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and MouthwashParticipants assigned to this arm will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks according to standardized instructions. |
| Lacalut Toothpaste Group | Active comparator | Drug: Lacalut White and Repair ToothpasteParticipants assigned to this arm will use Lacalut® White \& Repair toothpaste three times daily for 8 weeks according to standardized instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female participants aged 18 to 65 years
- Individuals with mild to moderate tooth staining
- Individuals with self-reported tooth sensitivity to hot, cold, sweet, or acidic stimuli
- Ability and willingness to comply with all study procedures
- Provision of written informed consent
Key exclusion criteria (8 listed)
- History of allergic reactions to any component of the study products
- Presence of clinically significant allergic disease
- Pregnant or lactating women
- Women of childbearing potential not using an acceptable method of contraception
- Individuals with severe tooth staining requiring professional treatment
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 |
|---|---|---|
| Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and MouthwashParticipants will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks by applying the product directly to the toothbrush and brushing for 2-3 minutes according to standardized instructions. | Drug | Scigates Toothpaste Group |
| Lacalut White and Repair ToothpasteParticipants will use Lacalut® White and Repair toothpaste three times daily for 8 weeks by applying the product directly to the toothbrush and brushing for 2-3 minutes according to standardized instructions. | Drug | Lacalut Toothpaste Group |
Primary outcome
Reduction in Tooth Sensitivity
Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8
Tooth sensitivity will be assessed using the Schiff Cold Air Sensitivity Scale. This is a 4-point ordinal scale ranging from 0 to 3, where: 0 = No response to air stimulus (best outcome) 1. = Response to air stimulus without request to discontinue 2. = Response with request to discontinue or movement away 3. = Painful response with request to discontinue (worst outcome) Interpretation: Lower scores indicate less tooth sensitivity (better outcome), while higher scores indicate greater sensitivity (worse outcome). Assessments will be performed at Baseline, Week 1, Week 2, Week 4, and Week 8.
Reduction in Dental Extrinsic Staining
Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8
Dental extrinsic staining will be assessed using the Modified Lobene Stain Index (MLSI). This index evaluates both extent and intensity of staining, each scored on a scale from 0 to 3: Extent of Staining (0-3): 0 = No stain 1. = Up to 1/3 of surface stained 2. = 1/3 to 2/3 of surface stained 3. = More than 2/3 of surface stained Intensity of Staining (0-3): 0 = No stain 1. = Light stain 2. = Moderate stain 3. = Heavy stain Scores from extent and intensity (for specified teeth) are summed to generate a composite score, with a possible range from 0 to 12. Interpretation: Lower scores indicate less staining (better outcome), while higher scores indicate more severe staining (worse outcome). Stain assessment will be performed on the labial surface of the upper left central incisor and upper left canine (or right counterparts if needed) at Baseline, Week 1, Week 2, Week 4, and Week 8.
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 14 Apr 2026.
- 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 Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash and Lacalut White and Repair Toothpaste in people with Dentin Hypersensitivity and Tooth Discoloration, run by Prof. Mayyas Al-Remawi at 1 site in Jordan.
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 8 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 14 Apr 2026. 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 Jordan. 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?
Reduction in Tooth Sensitivity (time frame: Baseline, Week 1, Week 2, Week 4, and Week 8). 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 14 Apr 2026.