Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity

Comparison of Fluoride Varnish With Two Different Desensitizers in Reducing Dentinal Hypersensitivity

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.

Study Overview

• Status: Unknown
• Conditions: Dentine Hypersensitivity
• Intervention / Treatment: Drug: 5% fluoride varnish; Drug: 8% arginine containing paste; Drug: Self-adhesive resin

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Robia Ghafoor, BDS,FCPS; Phone Number: 6467 02133106467; Email: robia.ghafoor@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Recruiting
      • Aga Khan University Hospital
      • Contact: Robia Ghafoor, BDS,FCPS; Phone Number: 02133106467; Email: robia.ghafoor@aku.edu
      • Sub-Investigator: Muhammad Hasan Hameed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluoride Varnish Group; 5% fluoride varnish (Acclean) applied topically	Drug: 5% fluoride varnish; Applied topically as a coating at single point in time; Other Names: Acclean
Active Comparator: Arginine paste Group; 8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically	Drug: 8% arginine containing paste; Applied topically as a coating at single point in time; Other Names: Colgate® Sensitive Pro-Relief™
Active Comparator: Adhesive Resin Group; Self-adhesive resin (Seal and Protect, Dentsply) applied topically	Drug: Self-adhesive resin; Applied topically as a coating at single point in time and light cured for 20 seconds; Other Names: Seal and Protect, Dentsply

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of hypersensitivity	• 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,; Subject responds to air stimulus but does not request discontinuation of stimulus; Subject responds to air stimulus and requests discontinuation or moves from stimulus; Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus	Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Muhammad Hasan Hameed, BDS, Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Anticipated): December 20, 2018
• Study Completion (Anticipated): December 20, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Fluoride varnish; Dentine Hypersensitivity; Desensitizing agents
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: 4714-Sur-ERC-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes