A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

Dentin Hypersensitivity Clinical Trial

Official title:

A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965039
• Other study ID #: 2019079
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: October 3, 2019

Study information

• Verified date: October 2020
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 3, 2019
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;
• sign a Confidentiality Disclosure Agreement (CDA);
• be in good general health as determined by the Investigator/designee;
• agree not to participate in any other oral/dental product studies during the course of this study;
• agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
• agree to refrain from the use of any non-study oral hygiene products*;
• exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
• have an absence of extensive calculus above the gum line;
• agree to return for all scheduled visits and follow study procedures; and
• have two teeth with a Schiff sensitivity score > 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)

Exclusion Criteria:

• having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;
• chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;
• any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;
• dental prophylaxis within 2 weeks prior to Baseline visit;
• having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;
• having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months;
• having teeth or periodontium with pathology or defects likely to cause pain;
• having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics;
• self-reported pregnancy or lactation;
• having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
• history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
• any diseases or condition that might interfere with the safe participation in the study;
• inability to undergo study procedures;
• having severe xerostomia;
• having had active caries within the 12 months;
• having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion;
• teeth will be excluded from study measurements if they:
• have deep, defective, or facial restorations;
• have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
• present with tendency for spontaneous bleeding;
• have been scaled/root planed or restored within the past 3 months.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Dipotassium oxalate toothpaste
Experimental dipotassium oxalate (3%) toothpaste

Drug:
• Stannous fluoride toothpaste
Marketed stannous fluoride (0.454%) toothpaste
• Potassium nitrate toothpaste
Marketed potassium nitrate (5%) toothpaste
• Sodium monofluorophosphate toothpaste
Marketed sodium monofluorophosphate (0.76%) toothpaste

Locations

Country	Name	City	State
United States	Silverstone Research Group	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Air Challenge	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.	4 weeks
Secondary	Baseline Air Challenge	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. The higher the Schiff score, the more sensitive the tooth.	Baseline
Secondary	Air Challenge	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.	3 days
Secondary	Air Challenge	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.	2 weeks
Secondary	Air Challenge	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.	8 weeks
Secondary	Air Challenge	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).	11 weeks
Secondary	Baseline Yeaple Probe	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.	Baseline
Secondary	Tactile Threshold	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.	3 days
Secondary	Tactile Threshold	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.	2 weeks
Secondary	Tactile Threshold	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.	4 weeks
Secondary	Tactile Threshold	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.	8 weeks
Secondary	Tactile Threshold	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).	11 weeks