Effect of CPP-ACP Associated With NaF or SnF₂ on Post-Bleaching Tooth Sensitivity
Summary
This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the efficacy of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) associated with sodium fluoride (NaF) or stannous fluoride (SnF₂) in reducing tooth sensitivity following in-office dental bleaching. Tooth bleaching with high-concentration hydrogen peroxide is widely used due to its effectiveness in improving dental aesthetics. However, tooth sensitivity remains the most common adverse effect associated with this procedure, negatively impacting patient comfort and satisfaction. Although several desensitizing strategies have been proposed, there is still no gold-standard protocol for managing post-bleaching sensitivity. CPP-ACP is a remineralizing agent capable of releasing calcium and phosphate ions, promoting mineral deposition on the tooth surface and potentially occluding dentinal tubules. When combined with fluoride, its effects may be enhanced. Sodium fluoride (NaF) has been widely used in dentistry, while stannous fluoride (SnF₂) has gained attention due to its additional protective and anti-sensitivity properties. Recent evidence suggests that the combination of CPP-ACP and SnF₂ may enhance mineral uptake and improve protective effects on dental tissues. A total of 66 participants will be randomly allocated into three groups (n=22): (1) CPP-ACP with NaF, (2) CPP-ACP with SnF₂, and (3) placebo control. All participants will undergo in-office bleaching with 35% hydrogen peroxide in two sessions, with a 7-day interval between sessions. Desensitizing agents or placebo will be applied before and after each bleaching session. Tooth sensitivity will be assessed using a numeric rating scale (NRS) and a visual analog scale (VAS) at multiple time points up to 72 hours after each session. Color changes will be evaluated using a spectrophotometer based on the CIELAB system. The study will test the hypothesis that CPP-ACP combined with fluoride agents reduces post-bleaching sensitivity without compromising whitening effectiveness. The findings may contribute to the development of more effective clinical protocols for managing bleaching-induced tooth sensitivity.
Timeline
- Start
- 2025-02-05
- Primary completion
- 2025-07-20
- Completion
- 2026-01-29
Publications
- Background Bouya S, Balouchi A, Maleknejad A, Koochakzai M, AlKhasawneh E, Abdollahimohammad A. Cancer Pain Management Among Oncology Nurses: Knowledge, Attitude, Related Factors, and Clinical Recommendations: a Systematic Review. J Cancer Educ. 2019 Oct;34(5):839-846. doi: 10.1007/s13187-018-1433-6.
- Background Chaves GC, Abi-Saab Arrieche M, Rode J, Mechali D, Reis PO, Alves RV, Stobbaerts E, Aguilar NG, Ribeiro I. [Estimating demand for anti-Chagas drugs: a contribution for access in Latin America]. Rev Panam Salud Publica. 2017 Jun 8;41:e45. doi: 10.26633/RPSP.2017.45. Spanish.
- Background Morsch P, Pereira GN, Navarro JH, Trevisan MD, Lopes DG, Bos AJ. [Clinical characteristics and social determinants in a sample of non-homebound elderly]. Cad Saude Publica. 2015 May;31(5):1025-34. doi: 10.1590/01021-311X00053014. Portuguese.
- Background Kim YH, Boykin E, Stevens T, Lavrich K, Gilmour MI. Comparative lung toxicity of engineered nanomaterials utilizing in vitro, ex vivo and in vivo approaches. J Nanobiotechnology. 2014 Nov 26;12:47. doi: 10.1186/s12951-014-0047-3.
- Background Oliveira Barros AP, da Silva Pompeu D, Takeuchi EV, de Melo Alencar C, Alves EB, Silva CM. Effect of 1.5% potassium oxalate on sensitivity control, color change, and quality of life after at-home tooth whitening: A randomized, placebo-controlled clinical trial. PLoS One. 2022 Nov 17;17(11):e0277346. doi: 10.1371/journal.pone.0277346. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPP-ACP+SnF2 | Unknown | — | Topical |
| Subject | CPP-ACPF | Unknown | — | Topical |