Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity

Dentine Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177109
• Other study ID #: 4714-Sur-ERC-17
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: June 2018
• Source: Aga Khan University
• Contact: Robia Ghafoor, BDS,FCPS
• Phone: 02133106467
• Email: robia.ghafoor[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• 5% fluoride varnish
Applied topically as a coating at single point in time
• 8% arginine containing paste
Applied topically as a coating at single point in time
• Self-adhesive resin
Applied topically as a coating at single point in time and light cured for 20 seconds

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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