Effect of Curodont D’Senz in subjects with hypersensitive teeth: a mono-centre, controlled, randomised, post-marketing study

Not Applicable

• Conditions: Dentine hypersensitivity; K03.8; Other specified diseases of hard tissues of teeth

• Registration Number: DRKS00012832
• Lead Sponsor: Zahnarztpraxis 32schönezähne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-05-04
• Study Start: 2017-08-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Summary of most important:
- At least one hypersensitive tooth
- Tooth hypersensitivity to mechanical and/or thermal stimulation
- Sensitive tooth showing abrasion, erosion or recession with exposure of cervical dentine
- Tooth with clinical diagnosis of moderate or severe dentine hypersensitivity: VAS score = 40 mm at study entry for at least 1 of 3 stimuli applied
- Willing and able to attend the on-study visits (D3, D7, D30 and D90)
- Written informed consent before participation in the study

Exclusion Criteria

Summary of most important:
- Professional desensitizing therapy during the previous 3 months; GLUMA application within 6 months
- Medical and pharmocological treatment – including psychiatric treatment – in particular chronic anti-inflammatory and analgesic medications
- Systemic disorders causing or predisposing to dental sensitivity
- Extensive dental restorations and reconstructions, prothesis, orthodontic appliances affecting the study zone / study tooth and teeth with a crown placed within one year or any other painful pathology or defect that (may) is the cause of pain.
- Active periodontal disease
- Periodontal surgery and/or orthodontics in the 3 month prior to study participation or planned during the participation
- Pregnant or lactating women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of dentine hypersensitivity assessed by Visual Analogue Scale (VAS) by subjects from baseline D0 to D7 (after 7 days of treatment) between Curodont D’Senz and elmex sensitive professional tooth paste<br>

Secondary Outcome Measures

Name	Time	Method
Change of dentine hypersensitivity between Curodont D’Senz and elmex sensitive professional tooth paste group assessed by subjects with:<br>a) VAS (visual analogue scale) from baseline D0 to D3, D30 and D90 (after 3, 30 and 90 days)<br>b) VRS (verbal response scale) from baseline D0 to D3, D7, D30 and D90<br>c) subject questionnaire at D3, D7, D30 and D90