Sensitivity, ToothPhase 1DentrificesNCT06273930
Reduction of Dentine Hypersensitivity After Use of Different Dentifrices
A Phase 1 study testing 5% CALCIUM SODIUM PHOSPHOSILICATE and 8% Arginine in people with Sensitivity, Tooth, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Tooth
- What is being tested?
- 5% CALCIUM SODIUM PHOSPHOSILICATE and 8% Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 30 Oct 2024
- Phase
- Phase 1
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be between 30 and 65 years old.
- Participants should be in good general health.
- Participants must have a diagnosis of generalized chronic periodontitis according to the 1999 classification definition.
- Participants should complain of at least two teeth with dentinal hypersensitivity.
- Participants must exhibit moderate to severe dentinal hypersensitivity (Schiff's scores of 2 to 3) or tactile stimulation (Visual Analogue Scale (VAS) score >4) after at least one scaling and root planing session.
Who cannot join
- Individuals with dentinal hypersensitivity symptoms prior to periodontal treatment.
- Those who have used agents to treat hypersensitivity in the past 3 months.
- Participants who are allergic to the test products (5% CSPS or 8% arginine).
- Dentinal hypersensitivity caused by factors such as dental caries, defective restorations, fractured teeth, abrasion or abfraction, extensively restored teeth, or restorations extending into the test area.
- Individuals who have undergone orthodontic treatment within the past 3 months.
- Patients with crowded teeth or serving as abutment teeth for fixed or removable prostheses are also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Dentine Hypersensitivity After Non-surgical Periodontal Therapy Comparing 5% Calcium Sodium Phosphosilicate and 8% Arginine Dentifrices: a Single Centre, Randomized Control Trial
To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis.
Read the detailed description
To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis. patients will be selected on the bases of inclusion and exclusion criteria.Descriptive statistics will be presented for both qualitative and quantitative variables
- Conditions
- Sensitivity, Tooth
- Being tested
- 5% CALCIUM SODIUM PHOSPHOSILICATE, 8% Arginine
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% CALCIUM SODIUM PHOSPHOSILICATEDrug
Calcium sodium phosphosilicate is a particulate, bioactive glass material that degrades in the aqueous oral environment to release calcium and phosphate ions, leading to formation of hydroxycarbonate apatite on the dentine surface result in reduction in dentine hypersenstivity
8% ArginineDrug
Arginine contributes to Whole Mouth Health. It also plays a role with respect to dental caries, helping to maintain a pH-neutral environment, and is proven to rapidly help relieve dentin sensitivity. Arginine is truly a remarkable ingredient now being used in oral care products.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Superiority parallel 3-arm randomized control trial. The intention behind a superiority trial is that CSPS \& Arginine are superior to commercially available desensitizing agents. Double blinded study (Participants and Outcome Assessor) Allocation ratio 1:1:1 Patients are chosen based on inclusion criteria. Patients undergo non-surgical periodontal therapy as part of their treatment. DH is assessed using the Schiff scale evaluation and tactile test Visual analogue Score (VAS) after treatment. 2 groups of patients receiving desensitizing agents applied for two consecutive 3-second applications, while others are placed in a control group. DH is evaluated again immediately using the Schiff scale and tactile test VAS after the application of desensitizing agents Patients are instructed to maintain their oral hygiene by brushing their teeth twice daily with a specific dentifrice provided to them along with a soft toothbrush. |
| 5% CSPS group | Active comparator | Superiority parallel 3-arm randomized control trial. The intention behind a superiority trial is that CSPS \& Arginine are superior to commercially available desensitizing agents.
Double blinded study (Participants and Outcome Assessor)
Allocation ratio 1:1:1
Patients are chosen based on inclusion criteria. Patients undergo non-surgical periodontal therapy as part of their treatment. DH is assessed using the Schiff scale evaluation and tactile test Visual analogue Score (VAS) after treatment.
2 groups of patients receiving desensitizing agents applied for two consecutive 3-second applications, while others are placed in a control group.
DH is evaluated again immediately using the Schiff scale and tactile test VAS after the application of desensitizing agents Patients are instructed to maintain their oral hygiene by brushing their teeth twice daily with a specific dentifrice provided to them along with a soft toothbrush. Receives: Drug: 5% CALCIUM SODIUM PHOSPHOSILICATE |
| 8% arginine group | Active comparator | Superiority parallel 3-arm randomized control trial. The intention behind a superiority trial is that CSPS \& Arginine are superior to commercially available desensitizing agents.
Double blinded study (Participants and Outcome Assessor)
Allocation ratio 1:1:1
Patients are chosen based on inclusion criteria. Patients undergo non-surgical periodontal therapy as part of their treatment. DH is assessed using the Schiff scale evaluation and tactile test Visual analogue Score (VAS) after treatment.
2 groups of patients receiving desensitizing agents applied for two consecutive 3-second applications, while others are placed in a control group.
DH is evaluated again immediately using the Schiff scale and tactile test VAS after the application of desensitizing agents Patients are instructed to maintain their oral hygiene by brushing their teeth twice daily with a specific dentifrice provided to them along with a soft toothbrush. Receives: Drug: 8% Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS.
Define pain and discomfort via running a probe on dentine of tooth The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). In some studies, horizontal scales are orientated from right to left.
Measured: within 8 weeks from the start of procedure
To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by Schiff scale.
Schiff Cold Air Sensitivity Scale: is a tool used to assess dentinal hypersensitivity (DH) or tooth sensitivity to cold air. It's a clinical method developed to quantify the severity of cold air sensitivity experienced by individuals with dentin hypersensitivity.
The scale typically ranges from 0 to 3, with the following descriptions:
0: No response to cold air
- Mild, brief, or localized response to cold air
- Moderate response to cold air, patient can tolerate
- Severe and prolonged response to cold air, patient finds it intolerable
Measured: within 8 weeks from the start of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Feb 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity, ToothStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Junaid Iqbal, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Muhammad J Iqbal, Principal investigator, AFID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273930
- Sponsor's protocol ID
- AFID
- Acronym
- Dentrifices
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Dentine Hypersensitivity After Non-surgical Periodontal Therapy Comparing 5% Calcium Sodium Phosphosilicate and 8% Arginine Dentifrices: a Single Centre, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06273930
- Acronym / sponsor ID
- Dentrifices / AFID
- Conditions
- Sensitivity, Tooth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Feb 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.
To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis.
Detailed description
To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis. patients will be selected on the bases of inclusion and exclusion criteria.Descriptive statistics will be presented for both qualitative and quantitative variables
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Superiority parallel 3-arm randomized control trial. The intention behind a superiority trial is that CSPS \& Arginine are superior to commercially available desensitizing agents. Double blinded study (Participants and Outcome Assessor) Allocation ratio 1:1:1 Patients are chosen based on inclusion criteria. Patients undergo non-surgical periodontal therapy as part of their treatment. DH is assessed using the Schiff scale evaluation and tactile test Visual analogue Score (VAS) after treatment. 2 groups of patients receiving desensitizing agents applied for two consecutive 3-second applications, while others are placed in a control group. DH is evaluated again immediately using the Schiff scale and tactile test VAS after the application of desensitizing agents Patients are instructed to maintain their oral hygiene by brushing their teeth twice daily with a specific dentifrice provided to them along with a soft toothbrush. |
| 5% CSPS group | Active comparator | Drug: 5% CALCIUM SODIUM PHOSPHOSILICATESuperiority parallel 3-arm randomized control trial. The intention behind a superiority trial is that CSPS \& Arginine are superior to commercially available desensitizing agents. Double blinded study (Participants and Outcome Assessor) Allocation ratio 1:1:1 Patients are chosen based on inclusion criteria. Patients undergo non-surgical periodontal therapy as part of their treatment. DH is assessed using the Schiff scale evaluation and tactile test Visual analogue Score (VAS) after treatment. 2 groups of patients receiving desensitizing agents applied for two consecutive 3-second applications, while others are placed in a control group. DH is evaluated again immediately using the Schiff scale and tactile test VAS after the application of desensitizing agents Patients are instructed to maintain their oral hygiene by brushing their teeth twice daily with a specific dentifrice provided to them along with a soft toothbrush. |
| 8% arginine group | Active comparator | Drug: 8% ArginineSuperiority parallel 3-arm randomized control trial. The intention behind a superiority trial is that CSPS \& Arginine are superior to commercially available desensitizing agents. Double blinded study (Participants and Outcome Assessor) Allocation ratio 1:1:1 Patients are chosen based on inclusion criteria. Patients undergo non-surgical periodontal therapy as part of their treatment. DH is assessed using the Schiff scale evaluation and tactile test Visual analogue Score (VAS) after treatment. 2 groups of patients receiving desensitizing agents applied for two consecutive 3-second applications, while others are placed in a control group. DH is evaluated again immediately using the Schiff scale and tactile test VAS after the application of desensitizing agents Patients are instructed to maintain their oral hygiene by brushing their teeth twice daily with a specific dentifrice provided to them along with a soft toothbrush. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be between 30 and 65 years old.
- Participants should be in good general health.
- Participants must have a diagnosis of generalized chronic periodontitis according to the 1999 classification definition.
- Participants should complain of at least two teeth with dentinal hypersensitivity.
- Participants must exhibit moderate to severe dentinal hypersensitivity (Schiff's scores of 2 to 3) or tactile stimulation (Visual Analogue Scale (VAS) score >4) after at least one scaling and root planing session.
Key exclusion criteria (6 listed)
- Individuals with dentinal hypersensitivity symptoms prior to periodontal treatment.
- Those who have used agents to treat hypersensitivity in the past 3 months.
- Participants who are allergic to the test products (5% CSPS or 8% arginine).
- Dentinal hypersensitivity caused by factors such as dental caries, defective restorations, fractured teeth, abrasion or abfraction, extensively restored teeth, or restorations extending into the test area.
- Individuals who have undergone orthodontic treatment within the past 3 months.
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 |
|---|---|---|
| 5% CALCIUM SODIUM PHOSPHOSILICATECalcium sodium phosphosilicate is a particulate, bioactive glass material that degrades in the aqueous oral environment to release calcium and phosphate ions, leading to formation of hydroxycarbonate apatite on the dentine surface result in reduction in dentine hypersenstivity | Drug | 5% CSPS group |
| 8% ArginineArginine contributes to Whole Mouth Health. It also plays a role with respect to dental caries, helping to maintain a pH-neutral environment, and is proven to rapidly help relieve dentin sensitivity. Arginine is truly a remarkable ingredient now being used in oral care products. | Drug | 8% arginine group |
Primary outcome
To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS.
Time frame: within 8 weeks from the start of procedure
Define pain and discomfort via running a probe on dentine of tooth The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). In some studies, horizontal scales are orientated from right to left.
To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by Schiff scale.
Time frame: within 8 weeks from the start of procedure
Schiff Cold Air Sensitivity Scale: is a tool used to assess dentinal hypersensitivity (DH) or tooth sensitivity to cold air. It's a clinical method developed to quantify the severity of cold air sensitivity experienced by individuals with dentin hypersensitivity. The scale typically ranges from 0 to 3, with the following descriptions: 0: No response to cold air 1. Mild, brief, or localized response to cold air 2. Moderate response to cold air, patient can tolerate 3. Severe and prolonged response to cold air, patient finds it intolerable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
Muhammad J Iqbal principal investigator
AFID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5% CALCIUM SODIUM PHOSPHOSILICATE and 8% Arginine in people with Sensitivity, Tooth, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 23 Feb 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Muhammad J Iqbal, BDS (03432656612, dr.muhammadjunaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS. (time frame: within 8 weeks from the start of procedure). 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 23 Feb 2024.