Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream

Phase 2

Completed

Conditions: Dentin Sensitivity

Interventions: Drug: Control toothpaste containing Novamin® technology
Drug: Control toothpaste containing 1500 ppm fluoride as MFP
Drug: Test toothpaste with nano-HAP (high concentration)
Drug: Test toothpaste with nano-HAP (low concentration)
Drug: Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3
Drug: Control toothpaste without nano-HAP
Drug: Test toothpaste with nano-HAP (medium concentration)
Drug: Test cream with nano-HAP (higher concentration)
Drug: Control cream without nano-HAP

Registration Number: NCT02918617

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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).

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 203

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control toothpaste containing Novamin® technology	Control toothpaste containing Novamin® technology	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP	Control toothpaste containing 1500 ppm fluoride as MFP	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)	Test toothpaste with nano-HAP (high concentration)	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)	Test toothpaste with nano-HAP (low concentration)	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and potassium nitrate (KNO3)	Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP	Control toothpaste without nano-HAP	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)	Test toothpaste with nano-HAP (medium concentration)	Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test cream with nano-HAP (higher concentration)	Test cream with nano-HAP (higher concentration)	Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP	Control cream without nano-HAP	Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation	Baseline to 8 weeks	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.
Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation	Baseline to 8 weeks	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
Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation	Baseline to 8 weeks	Patient's response to an air stimulus is recorded on a Dental Pain Scale (none\[1\]-mild\[2\]-moderate\[3\]-severe\[4\]).
Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation	Baseline to 8 weeks	Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none\[1\]-mild\[2\]-moderate\[3\]-severe\[4\]).