Effect of CPP-ACP Associated With NaF or SnF₂ on Post-Bleaching Tooth Sensitivity

NCT07506850 | Completed

• 1 other identifier: UFPara-2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tooth Sensitivity; Tooth Bleaching; Dentin Desensitizing Agents

Outcome Measures

Primary Outcomes (1)

• Tooth Sensitivity

  Use Kruskal-Wallis ANOVA for within-group analysis and Friedman's test for within-group sensitivity data analysis.

  "During bleaching", "1 hour after bleaching", "24 hours after bleaching", "48 hours after bleaching" and "72 hours after bleaching" in each whitening session.

Study Arms (3)

Control

PLACEBO COMPARATOR

In this group, an experimental paste without an active ingredient was used, mimicking the color, texture, and flavor of the experimental pastes.

Drug: Control (placebo)

CPP-ACPF

EXPERIMENTAL

n this group, an experimental paste of CPP-ACP combined with sodium fluoride.

Drug: CPP-ACPF

CPP-ACP+SnF2

EXPERIMENTAL

In this group, an experimental paste of CPP-ACP combined with stannous fluoride

Drug: CPP-ACP+SnF2

Interventions

CPP-ACPF DRUG

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.

CPP-ACPF

CPP-ACP+SnF2 DRUG

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.

CPP-ACP+SnF2

Control (placebo) DRUG

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older, of both sexes
• Good general and oral health
• Upper right canine classified as shade A2 or darker, according to the Vita Classical scale (VITA Zahnfabrik, Bad Säckingen, Germany)

You may not qualify if:

• Presence of active caries or periodontal disease
• Visible cracks in upper or lower anterior teeth
• Evident malocclusion
• Restorations or prostheses in anterior teeth
• Gastroesophageal disorders
• Severe intrinsic tooth discoloration (e.g., tetracycline staining, fluorosis, or non-vital teeth)
• Dentin exposure in anterior and/or posterior teeth
• Parafunctional habits
• Tooth sensitivity
• Previous tooth bleaching or orthodontic treatment
• Pregnant or lactating women
• Individuals with allergies or sensitivities to milk protein or hydroxybenzoate-based preservatives

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Universidade Federal do Pará

Belém, Pará, 66075-110, Brazil

Location

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• 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.

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  PMID: 25424549 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.

  PMID: 36395262 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Silva

  Universiade Federal do Pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Clínico

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 2, 2026
• Study Start: February 5, 2025
• Primary Completion: July 20, 2025
• Study Completion: January 29, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)