Clinical trial NCT06273930: Reduction of Dentine Hypersensitivity After Use of Different Dentifrices
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Sensitivity, Tooth
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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

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.

Primary outcomes:
measure: 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.
timeFrame: within 8 weeks from the start of procedure
measure: 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.
timeFrame: within 8 weeks from the start of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: AFID
Study officials:
affiliation: AFID
name: Muhammad J Iqbal
role: PRINCIPAL_INVESTIGATOR
References: