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Completed

NCT Number: NCT07478640

Bioadhesive Film of Acmella Oleracea (Jambu) in the Reduction of Post-bleaching Dental Sensitivity Caused by Bleaching With 35% Hydrogen Peroxide.

Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculdade de Odontologia da Universidade Federal do Pará

Belém, Pará, 66075-110, Brazil

About this study

Dental bleaching with hydrogen peroxide (HP) is a frequent treatment in dentistry, but it can present some adverse effects such as alterations in the surface structure of the teeth and tooth sensitivity. This study aimed to evaluate an experimental bioadhesive film of Acmella oleracea (jambu) extract on tooth sensitivity caused by bleaching with 35% hydrogen peroxide and its impact on the participants' oral health-related quality of life (OHRQoL). Seventy-two volunteers were divided into three different groups: GCP - Control group with bioadhesive bioplastic film without spilanthol, GKF - Desensitizing treatment group with 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and GAO - Group with the experimental bioadhesive film of Acmella oleracea extract. In each group, the corresponding product was applied to the vestibular surfaces of the visible teeth for 10 minutes. Subsequently, all groups underwent an in-office dental bleaching protocol with 35% hydrogen peroxide. Tooth sensitivity was measured using the visual analog scale (VAS), the impact on oral health-related quality of life (OHRQoL) was assessed using the QEDH-15 questionnaire at baseline and at the last sensitivity record, and color measurement was performed at two time points: at baseline and one week after the 3rd bleaching session. Data were subjected to the Shapiro-Wilk normality test. For normally distributed variables, we used repeated measures ANOVA for intragroup analysis and one-way ANOVA for intergroup comparisons, with post-hoc tests when applicable. For non-parametric data, Friedman (intragroup) and Kruskal-Wallis (intergroup) tests were used. Color analysis (ΔE), considering the difference between initial and final times, and the impact on oral health-related quality of life followed the same statistical criteria, according to the data distribution. The significance level adopted was 5% for all analyses. The bioadhesive film is expected to have an effect on nociception and reduce sensitivity caused by bleaching.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have at least 28 teeth in the cavity
  • good oral and general health

Exclusion criteria

  • active caries or periodontal disease
  • visible cracks in front teeth upper or lower
  • with evident malocclusion
  • restorations and prosthetics in teeth anterior teeth
  • gastroesophageal disorders
  • severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
  • dentin exposure in anterior teeth and /or later
  • parafunctional habits
  • tooth sensitivity
  • whitening treatment prior to or undergoing orthodontic treatment
  • Furthermore, smokers, pregnant or breastfeeding women do not will be included.

Treatment and study plan

Bioadhesive film of Acmella Oleracea (jambu)

Drug

Bioadhesive film of Acmella Oleracea (jambu) for topical application as a tape on teeth prior to teeth whitening with hydrogen peroxide.

Gel containing 5% potassium nitrate and 2% sodium fluoride.

Drug

Gel containing 5% potassium nitrate and 2% sodium fluoride for topical application to teeth prior to bleaching with hydrogen peroxide.

Spilanthol-free bioadhesive bioplastic film

Other

Spilanthol-free bioadhesive bioplastic film for topical application as a tape on teeth prior to bleaching with hydrogen peroxide.

Primary outcomes

  1. Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.

    Time frame: immediately after the procedure and during a 21-day treatment period.

    The bioadhesive film of Acemella Oleracea (jambu) reduces sensitivity related to teeth whitening with 35% hydrogen peroxide.

Secondary outcomes

  1. Changes in the color of teeth bleached with hydrogen peroxide.

    Time frame: one week after the last whitening session.

    Changes in the color of teeth bleached with hydrogen peroxide, even with the application of Acmella Oleracea (jambu) bioadhesive film.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

Application of Acmella Oleracea (Jambu) Bioadhesive Film in Reducing Tooth Sensitivity Induced by Dental Bleaching: a Randomized Clinical Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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