Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

NCT03232255 | Completed

• 1 other identifier: 100080
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in dentine hypersensitivity

  Assessed by subjects using VAS

  28 days

Study Arms (1)

Treatment Group

EXPERIMENTAL

Other: Mouthrinse (IQP-OLP-101)

Interventions

Mouthrinse (IQP-OLP-101) OTHER

Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one hypersensitive tooth in everyday life after PAV 1 in-office visit
• At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit
• At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry
• Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root
• 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
• Age ≥ 18 years and ≤ 75 years
• Willing and able to attend the on-study visits
• Willing and able to understand and to follow the study procedures and instructions
• Good oral hygiene throughout the study
• Written informed consent before participation in the study

You may not qualify if:

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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Praxisklinik ORS

Fellbach, 70736, Germany

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: August 25, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)