Skip to content

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

Effect of Curodont D’Senz in subjects with hypersensitive teeth: a mono-centre, controlled, randomised, post-marketing study - P11-4-PHyp

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012832
Enrollment
50
Registered
2017-08-04
Start date
2013-06-05
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Dentine hypersensitivity K03.8

Interventions

Group 1: Curodont D'Senz (tooth gel of self-assembling-peptide matrix P11-4): application for 7 subsequent days, 2x daily a small amount is locally applied on sensitive tooth Group 2: Elmex Sensitive

Sponsors

Zahnarztpraxis 32schönezähne
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

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

Countries

Germany

Contacts

Public ContactMarkus Schlee

Zahnarztpraxis 32schönezähne

post-von@32schoenezaehne.de+49 (0) 91 91/3 41 50 0

Outcome results

None listed

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