Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

NCT ID: NCT03232255

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-25

Study Completion Date

2017-12-07

Brief Summary

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

Detailed Description

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Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

Mouthrinse (IQP-OLP-101)

Intervention Type OTHER

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

Interventions

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Mouthrinse (IQP-OLP-101)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InQpharm Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Praxisklinik ORS

Fellbach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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100080

Identifier Type: -

Identifier Source: org_study_id

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