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Immediate Restoration After Bleaching and Retention Rate of Resin Restorations in Cervical Lesions

Does immediate restoration after bleaching affect retention rates of composite resin restorations in cervical lesions: a randomized, examiner-blind, noninferiority controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2t798hh
Enrollment
Unknown
Registered
2026-01-12
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Tooth Abrasion

Interventions

This is a randomized clinical trial with a split-mouth design, examiner-blinded (single-blind), and a non-inferiority approach, conducted at the university dental clinics. The study will include 60 pa
Group II, n = 60: restoration of a non-carious cervical lesion performed 14 days after bleaching), with 60 restorations per group. In the experimental group (Group I), one non-carious cervical lesion

Sponsors

Universidade Estadual de Ponta Grossa (UEPG)
Lead Sponsor
Universidade Estadual de Ponta Grossa (UEPG)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Good general health according to the American Society of Anesthesiologists physical status classification I or II; age 18 years or older; both sexes; satisfactory oral hygiene and absence of periodontal disease; presence of at least 20 teeth in functional occlusion; presence of at least six anterior teeth in the maxillary and mandibular arches free of caries, restorations, or previous endodontic treatment; canine shade A2 or darker according to the VITA Classical shade guide; presence of two non-carious cervical lesions with similar clinical characteristics regarding size, shape, dimensions, and color; non-retentive lesions with a depth greater than 0.5 mm involving enamel and dentin; lesions located on vital teeth up to the second premolar in either arch

Exclusion criteria

Exclusion criteria: Cavosurface margins involving more than 50% of the enamel; current use of fixed orthodontic appliances or presence of dental prostheses; severe tooth discoloration such as tetracycline staining, fluorosis, or non-vital teeth; unsatisfactory oral hygiene characterized by a Simplified Oral Hygiene Index greater than 3; moderate to severe or chronic periodontitis with probing depth greater than 4 mm, bleeding on probing, and clinical attachment loss greater than 3 mm in more than four teeth; severe bruxism associated with significant masticatory muscle pain, temporomandibular joint pain, or marked tooth wear; known history of allergy to resin-based materials, bleaching agents, or any substances used in the study; pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
It is expected to observe similar fracture and retention rates between restorations performed immediately after dental bleaching and those performed after a 14-day waiting period, within a noninferiority margin of 15%. This outcome will be assessed using clinical evaluation according to the criteria of the International Dental Federation (FDI). The parameters will be presented using success and failure rates, Kaplan–Meier survival analysis, hazard ratios, and 95% confidence intervals

Secondary

MeasureTime frame
It is expected that marginal adaptation of the restorations will not show significant differences between the two evaluated groups. This outcome will be assessed through clinical evaluation using the International Dental Federation (FDI) criteria. The presentation of parameters will include the International Dental Federation (FDI) classification (very good, good, satisfactory, unsatisfactory, poor) and statistical analysis using the Kruskal–Wallis test;It is expected that the shape and contour of the restorations will not show significant differences between the groups. This outcome will be clinically assessed using the International Dental Federation (FDI) criteria. The presentation of parameters will be based on the International Dental Federation (FDI) scores, with statistical analysis performed using the Kruskal–Wallis test;It is expected that marginal staining will not show significant differences between the experimental and control groups. This outcome will be assessed through clinical evaluation according to the International Dental Federation (FDI) criteria, with parameters presented using the International Dental Federation (FDI) scores and statistical analysis performed using the Kruskal–Wallis test;It is expected that the rate of caries recurrence around the restorations will not show significant differences between the groups. This outcome will be assessed through clinical evaluation using the International Dental Federation (FDI) criteria. The parameters will include the International Dental Federation (FDI) classification and statistical analysis using the Kruskal–Wallis test

Countries

Brazil

Contacts

Public ContactLaryssa Barbosa

Universidade Estadual de Ponta Grossa (UEPG)

24030880015@uepg.br+55(42)32203184

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026