Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate on Dentinal Hypersensitivity

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Dentinal Hypersensitivity

Treatments: Other: 5% fluorocalcium phosphosilicate dentifrice; Other: Calcium sodium phosphosilicate; Other: Placebo dentrifice

Study type: Interventional

Funder types: Other

Identifiers

NCT03741309

GDCRI/ACM/PG/Ph.D/5/2016-2017N

Details and patient eligibility

About

Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Full description

A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Enrollment: 131 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.

Exclusion criteria

• Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

131 participants in 3 patient groups, including a placebo group

Group I

Active Comparator group

Description:

dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks.

Treatment:

Other: 5% fluorocalcium phosphosilicate dentifrice

Group II

Sham Comparator group

Description:

dentifrice containing Calcium sodium phosphosilicate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .

Treatment:

Other: Calcium sodium phosphosilicate

Group III

Placebo Comparator group

Description:

dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks.

Treatment:

Other: Placebo dentrifice