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OpenTrials
Completed

NCT Number: NCT03405259

A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.

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Key information

Conditions

Dentinal Hypersensitivity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be at least 18 years of age;
  • provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • be in good general health as determined by the Investigator/designee; and
  • have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.

Exclusion criteria

  • allergy to rosin or to pine nuts;
  • self-reported pregnancy or nursing;
  • severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
  • active treatment for periodontitis;
  • fixed facial orthodontic appliances;
  • any diseases or conditions that might interfere with the safe completion of the study; or
  • an inability to undergo any study procedures.

Treatment and study plan

Super Seal® Desensitizer

Device

Single dose professional application.

Acclean® Fluoride Varnish

Device

Single dose professional application.

Primary outcomes

  1. Change From Baseline Air Challenge

    Time frame: Within 5 minutes after treatment was applied

    The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.

  2. Change From Baseline Visual Analog Scale

    Time frame: Within 5 minutes after treatment was applied

    Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2018
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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