Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity

Aga Khan University

Status and phase: Unknown; Phase 3

Conditions: Dentine Hypersensitivity

Treatments: Drug: 8% arginine containing paste; Drug: 5% fluoride varnish; Drug: Self-adhesive resin

Study type: Interventional

Funder types: Other

Identifiers

NCT03177109

4714-Sur-ERC-17

Details and patient eligibility

About

This is a single center, randomized control. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and four weeks.

Full description

The aim of the present study is to evaluate the efficacy of three common professionally applied desensitizing agents in the reduction of dentine hypersensitivity over a period of 4 weeks. Patients presenting to the dental clinic with Dentine hypersensitivity and fulfilling the inclusion criteria will be included in the study after taking informed consent. Participants will be divided into three groups. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). the subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and at four weeks by another dentist who would be a blind assessor.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with age 18 and above with dentine hypersensitivity will be selected.
• At least two hypersensitive teeth which will be sensitive to air blast (Schiff air sensitivity scores of 2 or 3) and positive tactile sensitivity assessed clinically with explorer
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion criteria

• • Patients who would have undergone any periodontal procedure or gotten any professionally applied desensitizers in the last three months.

  • Patients having generalized sensitivity in all teeth
  • Chronic use of anti-inflammatory and analgesic medications
  • Pregnant or lactating females;
  • Any denture bridgework; active cervical caries or deep abrasion requiring Class V fillings;
  • Fractured, crowned or root filled teeth and teeth with large restorations
  • Carious teeth or cracked teeth assessed on the basis of clinical judgment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Fluoride Varnish Group

Active Comparator group

Description:

5% fluoride varnish (Acclean) applied topically

Treatment:

Drug: 5% fluoride varnish

Arginine paste Group

Active Comparator group

Description:

8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically

Treatment:

Drug: 8% arginine containing paste

Adhesive Resin Group

Active Comparator group

Description:

Self-adhesive resin (Seal and Protect, Dentsply) applied topically

Treatment:

Drug: Self-adhesive resin