Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity

Phase 3

• Conditions: Dentine Hypersensitivity
• Interventions: Drug: 5% fluoride varnish; Drug: 8% arginine containing paste; Drug: Self-adhesive resin

• Registration Number: NCT03177109
• Lead Sponsor: Aga Khan University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-06-29
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fluoride Varnish Group	5% fluoride varnish	5% fluoride varnish (Acclean) applied topically
Arginine paste Group	8% arginine containing paste	8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically
Adhesive Resin Group	Self-adhesive resin	Self-adhesive resin (Seal and Protect, Dentsply) applied topically

Primary Outcome Measures

Name	Time	Method
Reduction of hypersensitivity	Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks	• Investigators are comparing the effectiveness of three professionally applied desensitizing agents, 8% arginine containing paste (Colgate® Sensitive Pro-Relief™), 5% fluoride varnish (Acclean) and self-adhesive resin (Seal and Protect, Dentsply) in reducing the dentine hypersensitivity immediately after application and at 2 and 4 weeks follow-up.The measurements of sensitivity will be determined by patient's response to air blast stimuli. Subjective responses will be recorded using Schiff Cold Air Sensitivity Scale which is scored as follows: 0 Subject does not respond to air stimulus,; 1. Subject responds to air stimulus but does not request discontinuation of stimulus; 2. Subject responds to air stimulus and requests discontinuation or moves from stimulus; 3. Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan