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A clinical study to evaluate how effective a dental strip containing an oxalate formulation is at reducing dentine hypersensitivity

A clinical study to evaluate the efficacy of an oxalate strip on dentinal hypersensitivity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10406748
Enrollment
100
Registered
2016-08-02
Start date
2016-07-07
Completion date
Unknown
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentine hypersensitivity Oral Health

Interventions

Part 1 (clinical study) Adult participants who report dentine hypersensitivity will be recruited to the study. At screening, participants who have given informed consent will be assess

Sponsors

The Proctor and Gamble Company (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Both part 1 and part 2: 1. At least 18 years of age 2. In good general health 3. Able to follow study procedures 4. Have at least one tooth with a Schiff sensitivity score of 2 in response to a cool air challenge

Exclusion criteria

Exclusion criteria: 1. Severe periodontal disease 2. Active treatment for periodontitis 3. Any medical condition requiring pre-medication prior to dental procedures 4. Any disease or condition that might interfere with the participant completing the study safely 5. Fixed orthodontic appliances 6. A history of kidney stones 7. Self-reported pregnancy or nursing 8. Daily doses of medication that interfere with pain perception such as anti-inflammatory drugs, anti-depressants, sedatives, antihistamines 9. Use of desensitising toothpastes within the 3 months prior to the screening visit 10. Allergy to ingredients in commercial dental products, such as potassium oxalate, potassium sorbate 11. Analgesia within the 8 hours prior to screening

Design outcomes

Primary

MeasureTime frame
Part 1: Dentine hypersensitivity as measured by examiner reported Schiff and patient-reported VAS in response to cool air and tactile stimuli. Measured at baseline, after 2 weeks, after 4 weeks Part 2: Tubule occlusion score as determined by assessment of scanning electron microscope images. Measured at baseline and after 2 weeks

Secondary

MeasureTime frame
Part 1: Participants' perceived dentine hypersensitivity as determined by questionnaire. Measured at baseline, after 2 weeks, after 4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026