Reduction of Dentine Hypersensitivity After Use of Different Dentifrices

NCT06273930 | Recruiting Phase 1 DMC

• 1 other identifier: AFID
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sensitivity, Tooth

Outcome Measures

Primary Outcomes (2)

• 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.

  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 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

  within 8 weeks from the start of procedure

Study Arms (3)

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.

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.

Drug: 8% Arginine

Interventions

5% CALCIUM SODIUM PHOSPHOSILICATE DRUG

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

5% CSPS group

8% Arginine DRUG

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.

8% arginine group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

AFID

Rawalpindi, Pakistan

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Arginine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Muhammad J Iqbal

  AFID

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad J Iqbal, BDS

CONTACT

03432656612; dr.muhammadjunaid@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 23, 2024
• Study Start: February 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 30, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

PA (1)