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An exploratory clinical study on the treatment of dentin hypersensitivity with PCCP desensitiser

An exploratory clinical study on the treatment of dentin hypersensitivity with PCCP desensitiser

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085992
Enrollment
Unknown
Registered
2024-06-22
Start date
2024-06-22
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Dentin hypersensitivity

Interventions

Group 1:Application of PCCP solution for the treatment of dentin hypersensitivity
Group 2:Application of PCCP solution to the dentin of vital pulp teeth. The sealing status of dentin tubules will be observed under transmission electron microscopy, and the status of inflammatory rea

Sponsors

The Affiliated Hospital of Stomatology, School of Stomatology, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Part I: 1. Patients aged 18-75 years; 2. Patients with dentin hypersensitivity whose preoperative VAS scores for tactile stimulation, airflow stimulation, and temperature stimulation are greater than or equal to 3; 3. The teeth cervical defect do not require filling, the depth of the defect is less than 0.5 mm; 4. Teeth free of caries and have not undergone restorative treatment; 5. Teeth have normal pulp vitality, no pulpitis, apical periodontitis, periodontal pocket probing depth is less than or equal to 5mm; 6. Teeth have no history of dental traumatic disease in the last 3 months; 7. Patients have not received teeth whitening treatment within the last 3 months; 8. Patients have not received periodontal surgery in the last 3 months, routine supragingival cleaning and subgingival scraping can be included; but need to meet the test period temporarily do not accept other forms of medical desensitisation treatment, periodontal supragingival cleaning and subgingival scraping requirements; 9. Patients with good general health status, without history of neurological or psychiatric diseases and related drug treatment history. Part II: 1. Teeth need to be extracted due to orthodontic treatment requirements, periodontal disease or tooth impaction; 2. Teeth free of caries and can be extracted intact.

Exclusion criteria

Exclusion criteria: Part I: 1. Patients younger than 18 years or older than 75 years; 2. Patients with wedge-shaped defects with a depth greater than or equal to 0.5mm, reaching the deep dentin layer and requiring filling treatment; 3. Teeth have been directly or indirectly restored, such as filling, inlay, veneer, partial crown, etc.; 4. Teeth have pulpitis, apical periodontitis or periodontal pockets with probing depth greater than 6mm; 5. Teeth have the following traumatic medical history: fracture, cracked tooth syndrome, dental concussion, acute co-trauma, etc.; 6. Patients have had teeth whitening treatment in the last 3 months; 7. Patients have a history of periodontal surgical treatment within the last 3 months, etc; 8. Patients with a history of neurological or psychiatric diseases, or a history of treatment with anticonvulsants, sedatives, antidepressants or analgesics and other related medications; 9. Females in pregnancy or breastfeeding; 10. Preoperative VAS scores for tactile stimulation, airflow stimulation, and temperature stimulation were less than 3. Part II: 1. Teeth that are decayed or cannot be extracted intact; 2. Patients with mental disorders who are unable to cooperate with the treatment; 3. Female patients during pregnancy or lactation; 4. Patients with uncontrolled serious systemic diseases; 5. Teeth that have undergone root canal treatment or restoration.

Design outcomes

Primary

MeasureTime frame
Visual analog scale (VAS) score;

Secondary

MeasureTime frame
Oral Health Impact Profile (OHIP-14);

Countries

China

Contacts

Public ContactFu Baiping

The Affiliated Hospital of Stomatology, School of Stomatology, Zhejiang University School of Medicine

fbp@zju.edu.cn+86 139 5801 9971

Outcome results

None listed

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