Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Other: Mouthrinse (IQP-OLP-101)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Fellbach, Germany, 70736
    • Praxisklinik ORS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At least one hypersensitive tooth in everyday life after PAV 1 in-office visit
2. At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit
3. At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry
4. Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root
5. For subjects entering the study at stage PAR-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery
6. Age ≥ 18 years and ≤ 75 years
7. Willing and able to attend the on-study visits
8. Willing and able to understand and to follow the study procedures and instructions
9. Good oral hygiene throughout the study
10. Written informed consent before participation in the study
11. Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)

Exclusion Criteria:

1. Hypersensitivity only due to sweets
2. Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate
3. Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months
4. Chronic systemic anti-inflammatory and analgesic medications
5. Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.)
6. Teeth or supporting structures with any other painful pathology or defect
7. Subject with poor health conditions
8. Concurrent participation in another clinical trial
9. Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group	Other: Mouthrinse (IQP-OLP-101); Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dentine hypersensitivity	Assessed by subjects using VAS	28 days

Collaborators and Investigators

• Sponsor: InQpharm Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2017
• Primary Completion (ACTUAL): December 7, 2017
• Study Completion (ACTUAL): December 7, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: 100080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No