Reduction of Dentine Hypersensitivity After Use of Different Dentifrices
NCT ID: NCT06273930
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
87 participants
INTERVENTIONAL
2024-02-01
2024-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
NCT04249336
Reduction of Dentine Hypersensitivity Using 8% Arginine Based Toothpaste and 8% Strontium Acetate Based Toothpaste (DH)
NCT03061383
8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin
NCT03068533
Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity
NCT06216262
Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy
NCT02829879
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
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.
No interventions assigned to this group
5% CSPS group
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% CALCIUM SODIUM PHOSPHOSILICATE
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% arginine group
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.
8% Arginine
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
5% CALCIUM SODIUM PHOSPHOSILICATE
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% Arginine
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants should be in good general health.
3. Participants must have a diagnosis of generalized chronic periodontitis according to the 1999 classification definition.
4. Participants should complain of at least two teeth with dentinal hypersensitivity.
5. 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.
Exclusion Criteria
2. Those who have used agents to treat hypersensitivity in the past 3 months.
3. Participants who are allergic to the test products (5% CSPS or 8% arginine).
4. 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.
5. Individuals who have undergone orthodontic treatment within the past 3 months.
6. Patients with crowded teeth or serving as abutment teeth for fixed or removable prostheses are also excluded from the study.
30 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Armed Forces Institute of Dentistry, Pakistan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muhammad Junaid Iqbal
Principle investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Muhammad J Iqbal
Role: PRINCIPAL_INVESTIGATOR
AFID
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AFID
Rawalpindi, , Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Muhammad J Iqbal
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AFID
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.