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.

Conditions

• Tooth Sensitivity

Interventions

DRUG

CPP-ACPF

Apply MI Paste Plus to the buccal surface of the teeth for five minutes. During this time, the patient should keep their mouth closed and should not talk or move. This procedure was performed on arm 2.

DRUG

CPP-ACP+SnF2

Apply MI Paste One Perio to the buccal surface of the teeth for five minutes. During this time, the patient should keep their mouth closed and should not talk or move. This procedure was performed on arm 3.

DRUG

Control (placebo)

This intervention was performed on arm 1. A placebo paste was applied to the buccal surface of the teeth for five minutes. During this period, the patient had to keep their mouth closed and not speak or move.

Sponsors & Collaborators

• Universidade Federal do Para

  lead OTHER

Principal Investigators

• Silva · Universiade Federal do Pará

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-05

Primary Completion

2025-07-20

Completion

2026-01-29

Countries

• Brazil

Study Locations