Reduction of Dentine Hypersensitivity After Use of Different Dentifrices

Sensitivity, Tooth Clinical Trial

— Dentrifices  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273930
• Other study ID #: AFID
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Armed Forces Institute of Dentistry, Pakistan
• Contact: Muhammad J Iqbal, BDS
• Phone: 03432656612
• Email: dr.muhammadjunaid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: October 30, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Sensitivity, Tooth

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Pakistan	AFID	Rawalpindi

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Institute of Dentistry, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	within 8 weeks from the start of procedure