Reduction of Dentine Hypersensitivity After Use of Different Dentifrices (Dentrifices)

Armed Forces Institute of Dentistry, Pakistan

Status and phase: Enrolling; Phase 1

Conditions: Sensitivity, Tooth

Treatments: Drug: 5% CALCIUM SODIUM PHOSPHOSILICATE; Drug: 8% Arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT06273930

AFID

Details and patient eligibility

About

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.

Full 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

Enrollment: 87 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants must be between 30 and 65 years old.
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

1. Individuals with dentinal hypersensitivity symptoms prior to periodontal treatment.
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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

87 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: 5% CALCIUM SODIUM PHOSPHOSILICATE

8% arginine group

Active Comparator group

Description:

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.

Treatment:

Drug: 8% Arginine