Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02918617
Other study ID # HSC20150221H
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2015
Est. completion date September 2016

Study information

Verified date October 2018
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin® technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP).


Description:

This is a double-blind, randomized, controlled, parallel group, outpatient clinical trial, involving a total of 270 patients diagnosed with dentin hypersensitivity, who will be randomly assigned to nine treatment groups of 30 patients each. Males or females of age 18 to 80 years will be enrolled. The nine groups will be randomly assigned to use one of the nine test products: (1) toothpaste containing nano-HAP (high concentration); (2) toothpaste containing nano-HAP (low concentration); (3) toothpaste containing nano-HAP and potassium nitrate (KNO3); (4) toothpaste containing NovaMin; (5) standard fluoride toothpaste with 1500 ppm MFP; (6) toothpaste containing nano-HAP (medium concentration); (7) placebo toothpaste; (8) cream containing nano-HAP; (9) placebo cream. Subjects will be instructed to use the study toothpaste as their sole oral hygiene product for the 8 weeks treatment duration while the cream will be applied with a retainer tray for 5 minutes before bed at night. For those using toothpastes, subjects will be instructed to brush their teeth twice daily for 2 minutes, morning and last thing before bed, applying on each occasion a one-inch strip of their assigned toothpaste on a wetted commercially available soft-bristled toothbrush. Dentin hypersensitivity examination, which will include air blast sensitivity and cold thermal sensitivity combined with visual analog scale and Dental Pain Scale, will be conducted at baseline, 2, 4, 6, and 8 weeks. Subjects will be screened for adverse effects on every visit, and all observed adverse events will be recorded when they occur.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Must be between the ages of 18 and 80, inclusive

- Must be in good general health based on medical history and oral soft and hard tissue examinations

- Must be willing and able to provide informed consent

- Must be able to read and comprehend study materials

- Must have access to a phone for regular study contact

- Must be willing to use the assigned products according to instructions, and be availability for appointments.

- Must have been diagnosed of having dentin hypersensitivity by a dentist, with at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession

- As a final entrance criteria, the sensitive tooth must respond to:

- air sensitivity, with Schiff score >1, assessed by use of a one-second blast of air.

- thermal sensitivity, assessed with frozen cotton pellet, with a pain rating of at least moderate pain on the Dental Pain Scale (DPS) and a score between 30 and 80 mm on a 100 mm scale on the Visual Analog Scale (VAS).

Exclusion Criteria:

- Subjects who answer YES to any of the following questions will not be enrolled into the study:

- Any history of significant adverse effects following use of oral hygiene products such as toothpastes and mouthwashes?

- Does the subject have any physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, mouthrinsing, etc.)?

- The sensitive tooth is associated with concomitant oral pain due to any other condition such as: soft-tissue lesions or toothache from other dental conditions like dental caries, etc?

- Has the subject ever reported allergy to drugs or chemicals used in the trial?

- The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth?

- Will the subject receive dental treatment which may affect their participation (i.e. oral prophylaxis)?

- The sensitive tooth is associated with mobility > 1?

- Did the subject participate in a dental clinical trial involving oral care products within the past 30 days?

- Is the subject pregnant, nursing or planning to become pregnant during the course of the study (self-reported)?

- Does the subject have other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial?

- Does the subject have significant oral soft tissue pathology, based on the dentist's visual examination and at the discretion of the investigator?

- The sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns?

- Patients having pain from periodontal related causes but not dentin hypersensitivity?

- Previous professional desensitizing treatment?

- Subject use of over-the-counter desensitizing products within the previous 3 months?

- Subjects using medication which could interfere with the perception of pain?

- Eating disorders or conditions associated with vomiting?

- Systemic conditions that are etiologic or predisposing to dentinal hypersensitivity?

- Excessive dietary or environmental exposure to acids?

- The sensitive tooth was restored in the preceding 3 months?

- The sensitive tooth is an abutment tooth for fixed or removable prostheses?

- The sensitive tooth has extensive restorations or restoration extending into the test area?

- Patients below 18 years or above 80 years of age?

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Control toothpaste containing Novamin® technology

Control toothpaste containing 1500 ppm fluoride as MFP

Test toothpaste with nano-HAP (high concentration)

Test toothpaste with nano-HAP (low concentration)

Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3

Control toothpaste without nano-HAP

Test toothpaste with nano-HAP (medium concentration)

Test cream with nano-HAP (higher concentration)

Control cream without nano-HAP


Locations

Country Name City State
United States School of Dentistry, University of Texas Health Science Center San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio Sangi Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ayad F, Ayad N, Delgado E, Zhang YP, DeVizio W, Cummins D, Mateo LR. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in Mississauga, Canada. J Clin Dent. 2009;20(4):115-22. — View Citation

Clark GE, Troullos ES. Designing hypersensitivity clinical studies. Dent Clin North Am. 1990 Jul;34(3):531-44. Review. — View Citation

Gillam DG, Bulman JS, Jackson RJ, Newman HN. Efficacy of a potassium nitrate mouthwash in alleviating cervical dentine sensitivity (CDS). J Clin Periodontol. 1996 Nov;23(11):993-7. — View Citation

Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. — View Citation

Kakar A. A novel computer program for visual analogue scale (VAS). Journal of Dental Research 88 (Special Issue A): 1952, 2009.

Orro M, Truong T, De Vizio W, Miller S, Chu TC, Boylan D. Thermodontic stimulator--a new technology for assessment of thermal dentinal hypersensitivity. J Clin Dent. 1994;5 Spec No:83-6. — View Citation

Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain. Baseline to 8 weeks
Primary Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation Patient's response to cold stimulus is recorded on a Visual Analog Scale of 0-100 with 0 signifying no pain and 100 signifying the worst possible pain Baseline to 8 weeks
Primary Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). Baseline to 8 weeks
Primary Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). Baseline to 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT02753075 - A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice. N/A
Completed NCT06045026 - A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management N/A
Completed NCT02861664 - Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity N/A
Completed NCT02542943 - Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity N/A
Completed NCT02226562 - Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity Phase 2
Completed NCT02919202 - Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity N/A
Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
Completed NCT02923895 - To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) Phase 4
Withdrawn NCT03361774 - A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity Phase 2
Completed NCT02924350 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) N/A
Completed NCT05083052 - Propolis in Reducing Dentin Hypersensitivity N/A
Active, not recruiting NCT06150573 - A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching N/A
Completed NCT02937623 - To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) N/A
Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
Completed NCT02293044 - A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity N/A
Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT05750745 - A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population N/A
Not yet recruiting NCT06417580 - Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity Phase 2