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OpenTrials
Completed

NCT Number: NCT03232255

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Praxisklinik ORS

Fellbach, 70736, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)

Exclusion criteria

  • 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

Treatment and study plan

Mouthrinse (IQP-OLP-101)

Other

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

Primary outcomes

  1. Change in dentine hypersensitivity

    Time frame: 28 days

    Assessed by subjects using VAS

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2017
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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