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Use of Sodium Ascorbate before Restoration after Tooth Bleaching and its Impact on the Retention of Restorations in Cervical Lesions

Does the application of Sodium Ascorbate before immediate post-bleaching Restoration affect the retention rate of Composite Resin Restorations in Cervical Lesions? A randomized, controlled, double-blind, non-inferiority clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-99jm83b
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Abrasão Dentária

Interventions

This is a randomized, split-mouth, triple-blind, non-inferiority clinical trial conducted at the dental clinics of the university with a total of 52 participants providing 156 restorations, allocated
0.5 mm), involving both enamel and dentin. Individuals with moderate to severe periodontal disease, severe tooth discoloration, severe bruxism, orthodontic appliances or prostheses, allergy to resin-b

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 status according to the American Society of Anesthesiologists classification system — ASA I or ASA II. Minimum age of 18 years. Both sexes. Acceptable oral hygiene without periodontal disease. Presence of at least 20 teeth in occlusion. Presence of at least six upper and lower anterior teeth free of caries, restorations, or endodontic treatment. Canine color A2 or darker according to the VITA Classical shade guide. Presence of three non-carious cervical lesions comparable in size, shape, dimensions, and color. Non-retentive lesions, deeper than 0.5 mm, involving enamel and dentin, in vital teeth extending up to the second premolar in any mandibular or maxillary arch

Exclusion criteria

Exclusion criteria: Cavosurface margin involving more than 50% of the enamel. Use of orthodontic appliances or dental prostheses. Severe tooth discoloration such as tetracycline stains, fluorosis or non-vital teeth. Poor oral hygiene with Oral Hygiene Index–Simplified (OHI-S) score greater than 3. 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 with significant masticatory muscle pain, temporomandibular joint pain or extensive tooth wear. Known allergy to resin-based materials, bleaching agents or substances used in the study. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
It is expected that fracture/retention rates of restorations performed immediately after in-office bleaching (with or without prior sodium ascorbate application) will be similar to those performed after a 14-day waiting period, remaining within the 15% non-inferiority margin. Verified using clinical evaluation according to International Dental Federation (FDI) criteria. Parameter presentation will include success and failure rates, Kaplan–Meier estimates, hazard ratios, and 95% confidence intervals

Secondary

MeasureTime frame
Marginal adaptation is expected not to differ significantly among the three groups. Verified through clinical evaluation using International Dental Federation (FDI) criteria. Parameters will include International Dental Federation (FDI) scoring (very good, good, satisfactory, unsatisfactory, poor) and statistical analysis using the Kruskal–Wallis test;Form/contour of the restorations is expected not to differ significantly among groups. Verified clinically using International Dental Federation (FDI) criteria. Parameters will include International Dental Federation (FDI) scores and Kruskal–Wallis analysis;Marginal staining is expected not to differ significantly among groups. Verified by clinical evaluation according to International Dental Federation (FDI) criteria, with parameters presented through International Dental Federation (FDI) scoring and the Kruskal–Wallis test;Caries recurrence around restorations is expected not to differ significantly among groups. Verified through clinical evaluation using International Dental Federation (FDI) criteria. Parameters will include International Dental Federation (FDI) scoring and Kruskal–Wallis testing;Postoperative sensitivity is expected not to differ significantly among groups. Verified using a Visual Analog Scale (0–10 cm). Parameters will include maximum recorded values 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)