Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Other: Mouthrinse (IQP-OLP-101)

• Registration Number: NCT03232255
• Lead Sponsor: InQpharm Group

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Study Start: 2017-08-25
• Primary Completion: 2017-12-07
• Study Completion: 2017-12-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Mouthrinse (IQP-OLP-101)	-

Primary Outcome Measures

Name	Time	Method
Change in dentine hypersensitivity	28 days	Assessed by subjects using VAS

Trial Locations

Locations (1)

Praxisklinik ORS; 🇩🇪 Fellbach, Germany