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Clinical and laboratory evaluation of resin materials containing bioactive particles

Clinical and in vitro performance of resin materials containing the bioactive particle S-PRG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-96b5zp9
Enrollment
Unknown
Registered
2025-01-17
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Dentin sensitivity

Interventions

This study is a double-blind, randomised, split-mouth controlled clinical trial and will be described following the parameters established by CONSORT - Consolidated Standards of Reporting Trials. The
E06.323.428

Sponsors

Universidade Federal do Paraná - UFPR
Lead Sponsor
Universidade Federal do Paraná - UFPR
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants can be male or female; must be at least 18 and no more than 65 years old; have good oral hygiene; absence of periodontal disease; have at least 20 teeth in occlusion and of these three or more teeth must present noncarious cervical lesions (NCL) of the abfraction type; the lesions should be approximately 2 mm deep

Exclusion criteria

Exclusion criteria: Participants with caries activity; unsatisfactory oral hygiene conditions; severe bruxism or other parafunctional habits; periodontal disease and systemic complications; participants who have undergone orthodontic or hypersensitivity treatments in the past six months will be excluded; in addition to pregnant and lactating women; teeth with abfraction lesions that have an implant or total prosthesis as an antagonist will also not be included in the research

Design outcomes

Primary

MeasureTime frame
We hope to assess the survival and quality of the restorations by means of a clinical evaluation using criteria such as: 1. colour stability and translucency; 2. surface gloss/smoothness; 3. surface colour; 4. anatomical shape; 5. fracture and retention; 6. marginal adaptation/discolouration; 7. patient's functional perception; 8. post-operative hypersensitivity; 9. pulp vitality; 10. recurrence of the initial pathology; 11. dental integrity and 12. periodontal response. These variables will be classified as very good, clinically good, clinically sufficient/satisfactory, clinically unsatisfactory but amenable to repair or clinically poor.

Secondary

MeasureTime frame
Spontaneous post-operative sensitivity is expected to be assessed one week after the restorative procedure, by asking the patient if they felt any pain during the period using the visual analogue scale (VAS) and at baseline (7 days), 6 months, 1, 3 and 4 years.

Countries

Brazil

Contacts

Public ContactYasmine Pupo

Universidade Federal do Paraná - UFPR

yasmine.pupo@ufpr.br+55 (41) 999429928

Outcome results

None listed

Source: REBEC (via WHO ICTRP)