Clinical trial

Reduction of Dentine Hypersensitivity After Non-surgical Periodontal Therapy Comparing 5% Calcium Sodium Phosphosilicate and 8% Arginine Dentifrices: a Single Centre, Randomized Control Trial

Name

AFID

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.

Trial arms

Trial start

2024-02-01

Estimated PCD

2024-10-15

Trial end

2024-10-30

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

5% CSPS group

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.

Arms:

8% arginine group

Size

Primary endpoint

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.

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.

within 8 weeks from the start of procedure

Eligibility criteria

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.

Protocol

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Updated at

2024-02-23

1 organization

2 products

2 indications

Organization

Armed Forces Institute of Dentistry

Product

Calcium Sodium Phosphosilicate

Indication

Sensitivity

Indication

Dental Caries

Product

Arginine